Lubricant Eye Drops Research Articles

Ocular surface retention time and extensions of TFBUT of a lubricating eye drop

Abstract Purpose: The tear film in subjects with ocular dryness is often unstable and incapable of maintaining the protective qualities that are intrinsic to its structure and function. Until recently, lubricating eye drops have provided only transient relief from ocular dryness. The purpose of these studies is to determine if a lubricating eye drop, containing PG/PEG/HP‐Guar, will extend ocular protection. Methods: To compare the ocular residence time of lubricating eye drops, subjects with dry feeling eyes were administered a solution of Fluoroscein Isothiocyanate‐dextran mixed with a the eye drops. The residence time was measured by a scanning fluorometer. To compare TFBUT, subjects with moderately dry feeling eyes were administered a single drop of a lubricating eye drop. After instillation, TFBUT was measured at 0, 5, 10, 15, 20, 30, 45, 60, and 90 minutes. Results: Tear film retention of the PG/PEG/HP‐Guar product was significantly greater than a HPMC and a CMC lubricating eye drop. The product containing PG/PEG/HP‐Guar was measured in the tear film as much as 37 minutes post instillation, while the HPMC and CMC drops were only 25 and 23 minutes, respectively. The PG/PEG/HP‐Guar tear yielded a significantly greater increase in TFBUT from baseline at 45, 60, and 90 minutes post‐installation compared to eyes dosed with a CMC/Glycerin drop. Conclusions: Based on these results, it can be postulated that the extended duration of retention observed with the PG/PEG/HP‐Guar tear allows the necessary time for restructuring of the unstable tear film into a more stable tear film. This leads to a long‐term tear film stabilization and enhancement of TFBUT and ultimately, extended ocular surface protection

An Evaluation of Tear Film Breakup Time Extension and Ocular Protection Index Scores Among Three Marketed Lubricant Eye Drops

To report the performance of an artificial tear containing propylene glycol and polyethylene glycol as active demulcents with hydroxypropyl-guar as a gelling agent (Systane Lubricant Eye Drops; Alcon, Fort Worth, TX) and compare it with that of 2 artificial tears containing carboxymethylcellulose (Refresh Tears and Refresh Endura Lubricant Eye Drops; Allergan, Irvine, CA). This was a single-center, 3-visit, randomized, double-masked crossover study that evaluated the effect of Systane versus Refresh Tears and Refresh Endura using tear film breakup time (TFBUT) and ocular protection index (OPI) in subjects with dry eye (n = 50). TFBUT values (5, 10, 15, 20, 30, 45, and 60 minutes after instillation) divided by interblink interval (IBI) yielded OPI scores. Systane significantly improved TFBUT at 5, 10, 15, 20, and 60 minutes versus Refresh Tears and at 5, 10, 15, 20, and 30 minutes versus Refresh Endura. Systane OPI scores were significantly higher than Refresh Tears at 15 and 30 minutes and than Refresh Endura at 5 minutes. This study suggests that Systane Lubricant Eye Drops was more effective than Refresh Tears at prolonging TFBUT up to 20 minutes after instillation and more effective than Refresh Endura at prolonging TFBUT up to 30 minutes after instillation. These data show that Systane is an effective first-line dry eye therapy and a superior ocular surface protector compared with Refresh Endura and Refresh Tears in the sample test population.

Use of Mitomycin C in the treatment of conjunctival and corneal squamous cell carcinoma. a case report

Abstract Purpose: Corneal conjunctival squamous carcinoma is a rare form of slowly progressive carcinoma of low malignant potential. Mitomycin C (MMC) is a chemiotherapic antibiotic isolated from Streptomyces Caespitosus and medical literature reports efficacy of MMC in the treatment of squamous cell carcinoma. We present a case of conjunctival and corneal squamous cell carcinoma which was treated with both surgical excision and topical use of MMC 0.02%. Methods: A 78‐year old man with a red‐grey vascularized elevated epithelial lesion that started at the conjunctiva and extended past the corneoscleral limbus on to the cornea for about 1.5 mm.The patient was given surgical exeresis of the conjunctival neoformation and the histological exam highlighted a corneal conjunctival squamous cell carcinoma. after three monthes a recurrence of the neoformation was displayed and we therefore decided to start topical MMC 0.02% eye drops treatment four times daily for 7 days. Four cycles of treatment were done with a one‐week interval during which only sodium hyaluronate 0.4% lubricant eye drops were administered. Results: During the period of treatment with the MMC 0.02% eye drops, the patient did not display any adverse systemic or ocular reactions. At the end of the treatment we found a complete regression of the disease. Twelve months after treatment he was without conjunctival and corneal epithelial dysplasia. Conclusions: This case highlights the efficacy of MMC 0.02% eye drops in the treatment of conjunctival and corneal squamous cell carcinoma that can avoid the topical use with sponge of MMC at higher concentration that it would present a not predictable long term effects on the conjunctival fornix and on lachrymal secretion.

Ocular surface in dry eye patients is improved after one month therapy with Systane

Abstract Purpose: Systane® Lubricating Eye Drops (Alcon Forth Worth, Inc.) is designed to provide relief from dry eye by means of longer retention time on the ocular surface, based on the presence of the combination of PEG400_PG and HP‐Guar (gelling hydroxypropyl‐Guar) which is believed to mimic the mucin layer of tear film. The effect of Systane was evaluated in an open trial on subjects with moderate symptoms. Methods: A total of 50 subjects were enrolled (age 57.6±15.4; 40 women, 10 men) ; inclusion criteria were based on a tear break‐up time (TBUT) < 10 sec without corneal epithelial staining. Six symptoms of ocular irritation were rated on a four‐point scale. Conjunctival hyperemia was graded. Patients were instructed to instill Systane four times a day for four weeks.. Satisfaction with the product was rated at the end of the study. Media of results in both eyes was considered for statistical evaluation; the Wilcoxon test for paired data was applied, p< 0,05 was considered as statistically significant. Results: All patients regularly instilled Systane and completed the follow‐up; results are expressed baseline vs endpoint. Significant reduction was demonstrated for ocular irritation symptom scores (1.44 vs 0.94, p 0.0001) while improvement was shown for patient’s satisfaction score (3.41 vs 3.94, p 0.0001) and TBUT (6.9±0.9 vs 8.5±1.5 sec, p 0.0001). A significantly increased proportion of patients with normal conjunctival injection (10 vs 22, results in %, p 0.01) was observed after one month follow up. Conclusions: Systane proved effective in reducing the symptoms of dry eye and it was overall well accepted. This finding is likely to be related with improved stability of tear film, due to the protective viscous layer bound to the corneal surface.

A phase I study of a CanAg-targeted immunoconjugate, huC242-DM4, in patients with Can Ag-expressing solid tumors

3062 Background: HuC242-DM4 is a novel, targeted anti-cancer agent in development for the treatment of CanAg-expressing tumors such as carcinomas of the colon and pancreas. The compound is formed by the conjugation of the potent cytotoxic maytansinoid drug, DM4, to the humanized monoclonal antibody, huC242. This agent was highly active across a broad spectrum of CanAg-expressing human tumor xenograft models. Methods: Patients were enrolled with metastatic or inoperable colorectal, pancreatic, and other CanAg-expressing tumors who have failed standard therapy (about 95% of pts. had received = 4 prior chemotherapy regimens). Results: Thirty patients were treated with huC242-DM4, receiving a single intravenous (IV) infusion once every three weeks. Cohorts of 3 patients initially were enrolled on each dose level. Patients have received huC242-DM4 at 18, 36, 60, 90, 126, 168, 223, and 297 mg/m2. To date, dose limiting toxicity (DLT) was experienced by two of six patients treated at the 223 mg/m2 dose level during their second cycle of treatment. The patients experienced decreased visual acuity, corneal deposits and keratitis. Both patients were subsequently treated with lubricating eye drops. At present, these adverse events have markedly improved in one patient, while the other patient has completely returned to baseline. Of 10 patients treated at the168 mg/m2 dose level (including two patients who were dose reduced to 168 mg/m2), seven patients have received at least two cycles of treatment. One patient had grade 3 diarrhea and dehydration during his second cycle at 168 mg/m2. The latter improved with intravenous fluids. Preliminary pharmacokinetic data reveal a half-life of huC242-DM4 of about 5 days in patients with low plasma CanAg levels. In patients with high plasma CanAg levels (>900 units/mL), clearance of huC242-DM4 is increased. There has been no clinically significant myelosuppression and no formation of antibody to humanized antibody (HAHA) or drug (HADA). One patient had a 36% decline in CEA (not associated with tumor shrinkage). Conclusions: HuC242-DM4 was well tolerated at the 168 mg/m2 dose level. The MTD is not yet defined and approaches to prevent /ameliorate ocular toxicity are planned. No significant financial relationships to disclose.

SmartPlug in the Management of Severe Dry Eye Syndrome

To evaluate long-term efficacy and safety of the SmartPlug in the management of severe dry eye syndrome. A retrospective chart review was conducted of patients who underwent SmartPlug insertion from June 2003 to December 2005. The clinical data collected included sex and age of the patients, indications for plug insertion, Schirmer tear function test with anesthesia, frequency of lubricant eye drop use before and after plug insertion, fluorescein staining at baseline and at last follow-up, and complications. There were 91 eyes of 54 patients (44 women and 10 men) in the study group. The average follow-up period was 13.0 +/- 6.0 months, with a minimum of 6 months. Thirty patients (55 eyes, 60.4%) reported a decreased use of lubricant eye drops after SmartPlug insertion, including 9 patients (14 eyes, 15.4%) who were free of supplementary lubricant eye drops. Forty-one patients (69 eyes, 75.8%) reported subjective symptom improvement after SmartPlug insertion. The corneal fluorescein staining showed overall reduction. Complications included canaliculitis (6 eyes, 6.6%), epiphora requiring plug removal (5 eyes, 5.5%), and spontaneous plug loss (2 eyes, 2.2%). SmartPlug can be effective in the management of severe dry eye syndrome. However, long-term follow-up is needed for potentially serious complications such as canaliculitis.

Clinical evaluation of the efficacy of PEG/PG lubricant eye drops with gelling agent (HP-Guar) for the relief of the signs and symptoms of dry eye disease: A review

The objective of this review is to evaluate the efficacy of polyethylene glycol (PEG) 400/propylen glycol (PG) in-situ gellable lubricant eye drops with HP-Guar (as the gelling agent) in reducing dry eye signs and symptom. A systematic literature search utilizing MEDLINE was conducted to identify peer-reviewed articles related to dry eye disease and in-situ PEG/PG gellable lubricant eye drops. The search covered the period prior to July 2007. Articles were selected based on their direct applicability to the subject matter. A manual search was also conducted based on citations in the published literature. Additional original reports were referenced at the author's discretion if deemed applicable to the subject matter of the review. Forty-three (43) articles were identified and are reviewed here. The published literature indicated that dry eye disease is a prevalent condition in the United States, especially among women and the elderly. The biphasic mechanism of action of in-situ PEG/PG gellable lubricant eye drops, afforded by their unique structure, renders them more effective at reducing the signs and symptoms of dry eye than many commercially available over-the-counter products.

Comparison of Topical Dry Eye Medications for the Treatment of Keratoconjunctivitis Sicca in a Botulinum Toxin B-Induced Mouse Model

To compare the effects of topical dry eye medications including anti-inflammatory agents and lubricant eyedrops for the treatment of keratoconjunctivitis sicca (KCS) in a botulinum toxin B (BTX-B)-induced mouse model. CBA mice were randomized into 10 groups. The first 5 groups received a transconjunctival injection of saline into the lacrimal gland, and the remaining groups were injected with 0.05 mL of 20 mU BTX-B. Each group received treatment with 0.1% fluorometholone (FML), 0.05% cyclosporine A (CsA), a 50:50 combination of FML and CsA, artificial tears, or saline 3 days after injections. Tear production, corneal staining, and blink rate were compared in each of the 10 groups. Tear production in BTX-B-injected CsA-treated, FML-treated, and combined-treated groups started to return to baseline level within 2 weeks of treatment, whereas those treated with saline or artificial tears still exhibited reduction of lacrimation up to 4 weeks after injection. Topical FML significantly reversed the staining score within 1 week of treatment. The improvement of corneal staining in BTX-B-challenged combined-treated and CsA-treated groups occurred later within 2 weeks after treatment. No significant improvement in corneal staining was observed for the BTX-B-injected mice treated with artificial tears or saline. No significant changes were noted in blink frequency between the control and study groups undergoing the various dry eye therapies. The therapeutic effects of dry eye medications in a BTX-B-induced mouse model of KCS are similar to the human response.

Evaluation of the Preserving Efficacy of Lubricant Eye Drops with a Novel Preservative System

Products provided in multidose containers must be adequately preserved in order to prevent contamination during repeated use. The aim of this study was to evaluate the ability of a lubricant eye drop formulation without traditional preservatives to control and prevent contamination under extreme microbial conditions. Bottles of a new lubricant eye drop with a novel preservative system (SYSTANE FREE Lubricant Eye Drops, Alcon Laboratories, Inc., Fort Worth, TX) were stored at elevated (40 degrees C) and room temperature (25 degrees C) for up to 1 year. The formulation was inoculated with microorganisms to contain high levels (approximately 1x10(6) colony forming units [cfu]/mL) of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus niger. The inoculated samples were stored at 20-25 degrees C during testing. Three types of tests were conducted: (1) tests with 1 inoculation, (2) tests with 2 inoculations over 28-day test periods, and (3) tests with 6 inoculations over a 6-month test period. Additionally, a comparison of the preservative efficacy of the SYSTANE FREE formulation to marketed products, including sodium perborate, stabilized oxychloro complex, and polyhexamethylene biguanide eye drops, was performed. In all studies, the number of survivors was determined using standard microbiological dilution pour-plate techniques. The results consistently showed that the SYSTANE FREE formulation meets preservative efficacy standards equally well, or better, than, marketed eye drop products. Even with multiple inoculations, the formulation repeatedly showed no recovery of the organisms. Though the SYSTANE FREE formulation contains no traditional preservatives, its unique blend of ions and buffers was capable of preventing contamination of the contents even after exposure to extreme conditions.

Effect of Topical Prednisolone and Diclofenac on the Short-Term Change in Morphology of Posterior Capsular Opacification

To observe and document the effect of steroidal and nonsteroidal antiinflammatory treatment on the formation of Elschnig pearls. A prospective, randomized, double blinded, placebo controlled, two-way-cross-over study. Thirty-nine eyes of 32 patients with pronounced, regeneratory posterior capsule opacification (PCO) were included. The patients were treated topically with prednisolone and diclofenac (verum) or with lubricating eye drops (placebo) four times daily for one week. After a wash-out period of two weeks the patients received the contrary treatment also four times daily for one week. Digital retroillumination images were taken at day one, three, five, eight, and 15 of each medication period. The changes in the size of 4,675 Elschnig pearls were analyzed. The mean cumulative area of all marked pearls/eye and follow-up was 1.2 mm(2) (range: 0.1 mm(2) to 3.2 mm(2)). The mean pearl size was 12,809 microm(2) (range: 60 microm(2) to 1.08 x 10(6) microm(2)). Between the follow-up examinations, 1,274 pearls disappeared (mean: 33 pearls/eye, range: five to 69 pearls; 27%) and 777 newly formed pearls appeared (mean: 20 pearls/eye, range: three to 53 pearls; 20%). There was no statistically significant difference in pearl size change and in number of disappeared and newly appeared pearls between the verum and the placebo treatments. Topical prednisolone and diclofenac do not influence the short-term change of Elschnig pearls. Elschnig pearls disappear and appear within days. The degree of progression and regression varies greatly among eyes.

Comparison of the relative toxicity of travoprost 0.004% without benzalkonium chloride and latanoprost 0.005% in an immortalized human cornea epithelial cell culture system

The purpose of this study was to compare the relative toxicity of a new topical ophthalmic glaucoma medication, travoprost 0.004% without benzalkonium chloride (BAK), with that of commercially available latanoprost 0.005% (preserved with 0.02% BAK) in immortalized human corneal epithelial cells (HCEs). Tissue culture plates (96 well) containing HCEs were divided into 6 groups. Two groups served as negative controls (70% methanol and gentamicin). Another 2 groups--1 in corneal epithelial culture media and the other in a hydroxypropyl (HP)-Guargellable lubricant eyedrop--served as live controls. The travoprost 0.004% without BAK and latanoprost 0.005% groups were exposed to 100 microL of the undiluted solutions. Cells were incubated for 25 min at 37 degree C. A live/dead assay was used to measure the effects of travoprost without BAK and of latanoprost on HCEs compared to 70% methanol and culture medium. Between the 2 glaucoma medications tested, travoprost 0.004% preserved without BAK showed significantly less toxicity on HCEs than did latanoprost 0.005%. This difference may have ramifications in terms of tolerability for patients who use these topical glaucoma drugs on a long-term basis.

The Effect of Lubricant Eye Drops on Ocular Wavefront Aberrations

To study the effect of lubricant eye drop instillation on ocular wavefront aberrations. The wavefront aberrations of the entire optical path of 30 eyes of 15 patients before and following instillation of lubricant eye drops (Bion Tears; Alcon Laboratories Inc, Ft Worth, Tex) were obtained over a 6-mm pupil using a Hartmann-Shack wavefront sensor (WaveScan; VISX Inc, Santa Clara, Calif). Additional computation of root-mean-square (RMS) errors of higher order aberrations from third to sixth order were done using Zernike Tool Software (VISX Inc). Main outcome measures include the mean changes of total higher order aberrations RMS, higher order aberrations, and point spread function (PSF) of the higher order aberrations. The mean changes of total higher order aberrations following instillation of lubricant eye drops on the right eyes were -0.07 microm (95% confidence interval [CI], -0.11 to -0.03) and -0.03 microm on the left eyes (95% CI, -0.07 to 0.01). Significant mean changes were noted for coma and trefoil aberrations with a magnitude of -0.08 microm (95% CI, -0.12 to -0.03) and -0.09 (95% CI, -0.13 to -0.05), respectively, as well as a mean change of the PSF of the higher order aberrations (-0.05 diopters, 95% CI, -0.08 to -0.02) on the right eyes. Although no significant changes in these parameters were demonstrated on the left eyes, a similar trend of changes was observed. Ocular wavefront aberrations may change following eye drop instillation as measured objectively by the WaveScan system. This effect should be taken into consideration in the assessment of patients for wavefront-guided laser vision correction procedures.

Inverse Bell's phenomenon observed following levator resection for blepharoptosis

Ptosis surgery is one of the more widely performed surgeries in ophthalmology. Preoperative lagophthalmos, Bell's phenomenon, corneal sensation and dry eye are important factors to be assessed in these cases, which influence the functional and cosmetic results. We herein describe the interesting complication of transient inversion of Bell's phenomenon observed following extensive levator resection performed for congenital ptosis. Three patients are described who underwent levator resection and showed an inversion of the Bell's phenomenon in the postoperative period, with the eye going down instead of up, during eyelid closure. The Bell's phenomenon reverted to normal in all three cases within 2 weeks and there were no corneal complications. The patients were given frequent lubricating eye drops during this period. It is important to look for variations in Bell's phenomenon in all cases of congenital ptosis, especially following levator resection. In cases with a poor or ineffective Bell's phenomenon, it is imperative to keep a close watch on the cornea along with copious lubrication during the early postoperative period.

The Effect of Two Novel Lubricant Eye Drops on Tear Film Lipid Layer Thickness in Subjects With Dry Eye Symptoms

Because the lipid layer of the tear film is recognized as a critical component in dry eye disease, this study was designed to determine if a single eye drop of either Soothe or Systane produces a significant increase in lipid layer thickness (LLT) for subjects reporting symptoms indicative of dry eyes. A double-blind, internally paired study was performed. A custom-built lipid layer interferometer, enabling characterization of lipid layer interference patterns, was used to quantify baseline LLT (OU) of eligible subjects. Inclusion criteria included: 1) presence of dry eye symptoms and 2) baseline LLT < or =75 nm. Subjects (n = 40) received a single eye drop of Soothe in one eye and a single eye drop of Systane in the contralateral eye. After the instillation of each test drop, LLT was reanalyzed for all subjects. The mean +/- standard error baseline LLT pre-eye drop instillation was 60.0 +/- 1.8 nm for eyes treated with Soothe and 61.5 +/- 1.8 nm for eyes treated with Systane. These means were not significantly different (p > 0.5). The mean LLT for eyes treated with Soothe increased to 124.4 +/- 4.9 nm (p < 0.0001). The mean LLT for eyes treated with Systane increased to 71.3 +/- 2.6 nm (p < 0.0001). The LLT increase from Soothe was significantly greater than that from Systane (p < 0.0001). In subjects with symptoms indicative of dry eye states and LLT < or =75 nm, one eye drop of Soothe more than doubled LLT, a 107% mean increase, whereas Systane increased LLT by 16%.

An open-label evaluation of HP‐Guar gellable lubricant eye drops for the improvement of dry eye signs and symptoms in a moderate dry eye adult population

ABSTRACTObjective: Evaluate the efficacy of a polymer hydroxypropyl guar (HP‐Guar) gellable lubricant eye drop (Systane* Lubricant Eye Drops) in reducing dry eye signs and symptoms among dry eye patients who exhibited at least moderate signs and symptoms.Methods: 168 patients with moderate dry eye signs and symptoms were enrolled at 29 sites in this open label study. The mean age of patients was 62 years with a minimum age of 28 years and a maximum of 90 years. One hundred and forty-seven patients completed the study, 111 female and 35 male, excluding 1 subject (gender not captured). In order to be included in the study, subjects were required to have a total corneal staining score ≥ 4 (NEI grid) in at least one eye, with a grade ≥ 2 in at least one zone of the same eye. Patients also had to indicate that their eyes ‘felt dry enough to want to use eye drops’ at least ‘some of the time’ on a standardized frequency scale. Eligible patients were dispensed a run-in drop (Opti-Free Express Rewetting Drops*) to use QID for 7 days, and then examined. Patients continuing to meet the inclusion criteria were dispensed the test drops (HP‐Guar gellable lubricant eye drops) to use QID, and re-examined on Day 28. At each visit, corneal and conjunctival staining were measured, and six ocular discomfort symptoms were rated on a standardized 0–4 severity scale. At Days 0 and 28, patients subjectively rated product acceptability using a Likert scale.Results: No significant changes in corneal or conjunctival staining were observed with the use of the run-in drop. After 28 days of test drop use, there was a statistically significant reduction in corneal staining ( p < 0.0001). Ninety-four percent of patients improved from baseline, with mean reduction in total corneal staining of 4.1 units (0–15 total scale) (62%). Conjunctival staining also improved significantly ( p < 0.0001) with a mean total reduction of 3.1 (59%). Patients experienced statistically significant symptomatic relief from day 0 to day 28 for all six ocular discomfort severity questions ( p < 0.0001).Conclusion: Lubricating drops effectively relieved signs and symptoms associated with moderate dry eye, with measurable improvements evident in both objective staining and subjective questionnaire measures after 28 days in this study population.

Rejuvenation of Visual Functions in Older Adult Drivers and Drivers with Cataract During a Short-Term Administration of N-Acetylcarnosine Lubricant Eye Drops

The purpose of this study was to examine using the original halometer glare test of the type of visual impairment mediated by the increased glare sensitivity (halos) and associated with poorer visual function in both the better and worse eyes of older adult drivers and older drivers with cataract. The clinically validated (by Innovative Vision Products Inc.) formula of 1% N-acetylcarnosine (NAC) lubricant eye drops were applied topically to the eyes of older drivers to reduce glare disability and improve distance acuities for driving. This was a randomized, double-blind, placebo-controlled study. The examined subjects consisted of 65 older adults with cataract in one or both eyes, and 72 adult drivers who did not have cataract in either eye. In the control group, comparison with baseline values showed some variability of data in gradual worsening of glare sensitivity at red and green targets and minimal VA changes over 4 months. In the NAC-treated group, 4-month follow-up generally showed an improvement in VA and a significant improvement in glare sensitivity at red and green targets was documented in worse and better eyes using a critical cut point halometer score for driving. The NAC-treated eyes had statistically significant difference in VA, glare sensitivity compared with the control group ( p < 0.001) at 4-month timepoint of treatment, as supported by the overall t-test results of the ratio of the follow-up data to the baseline values. Tolerability of NAC eyedrops was good in almost all patients, with no reports of ocular or systemic adverse effects. It would be advisable for traffic safety if a Halometer glare sensitivity test was implemented for vehicles and/or was regularly added to the requirements for a driver's licence. The results of this study provide a substantial basis for further evaluation of NAC in the treatment and prevention of vision impairment in the older population of drivers for legal driving. The developed ophthalmic drug NAC formula showed potential for the non-surgical treatment of age-related cataracts.

Clinical evaluation of an HP-guar gellable lubricant eye drop for the relief of dryness of the eye

Purpose. To evaluate the efficacy of a new lubricant eye drop containing polyethylene glycol 400 and propylene glycol demulcents with hydroxypropyl-guar as a gelling agent (Test Product) to a system with carboxymethylcellulose (Control Product) for reducing dry eye signs and symptoms. Methods. Eighty-seven dry eye volunteers were enrolled at seven sites for this six-week, concurrently controlled, double-masked clinical study. Results. The Test Product significantly reduced conjunctival staining (p = 0.025) and temporal corneal staining (p = 0.024) compared to the Control. The Test Product also significantly reduced symptoms of dryness in the morning and evening, compared to the Control (p = 0.015 and p = 0.023, respectively). Subjects in the Test treatment group reported lower frequencies of foreign body sensation and felt their eyes were “refreshed longer” compared to those in the Control group (p = 0.033 and p = 0.037, respectively). Conclusions. The Test Product was more effective at reducing both the signs and symptoms of dry eye compared to the carboxymethylcellulose containing Control.

Pre-clinical investigation of the efficacy of an artificial tear solution containing hydroxypropyl-guar as a gelling agent

Purpose. Pre-clinical studies of a new artificial tear product (SystaneTM Lubricating Eye Drops Alcon Laboratories, Inc., Fort Worth, TX) containing the novel gelling agent hydroxypropyl-guar (HP-guar) and two demulcents, polyethylene glycol 400 (PEG) and propylene glycol (PG) were conducted to determine the ability of the product to protect ocular surface epithelial cells from desiccation in vivo and in vitro, and to promote recovery of the damaged corneal epithelial barrier in vivo. Other leading artificial tear products were also evaluated as comparators to determine the relative effectiveness of different polymer systems. Methods. Damage due to desiccation was assessed by measuring corneal uptake of methylene blue compared to untreated corneas. Corneas of anesthetized rabbits were treated with the new artificial tear product and subjected to desiccation by holding the eyelids open for 2 hours with a speculum. Control eyes were subjected to desiccation without application of a tear formulation. To measure recovery of the corneal epithelium from damage, corneas of anethesthetized rabbits were exposed to 0.01% benzalkonium chloride (BAC) for 5 minutes to increase epithelial permeability. The corneas were exposed to the new artificial tear for 1.5 hours followed by measurement of uptake of 5,6 carboxyfluorescein (CF). In the desiccation and CF uptake experiments, the new tear product was also compared to a tear product formulation without HP-guar and to a commercially available artificial tear containing carboxymethyl cellulose (CMC) and Purite®. In a third set of experiments, immortalized human corneal epithelial cells and Chang conjunctival cells in culture were exposed to the PEG/PG/HP-guar tear product, the control formulation without HP-guar, a tear formulation preserved with BAC, or the artificial tear containing CMC/Purite® for 15 min. The tear formulation was removed and the cells were exposed to desiccating conditions in a laboratory safety hood for 10 or 30 min. Cell viability was determined using the MTT assay. Results. The in vivo desiccation model, showed that the new tear product, SystaneTM, offered complete protection of the cornea from desiccation (methylene blue uptake not different than naïve control). Following exposure to 0.01% BAC, the new artificial tear product also provided an environment in which the corneal epithelium recovered completely from damage (CF uptake not different than normal, untreated cornea). This level of protection was not observed when corneas were treated with other formulations. Results from the in vitro desiccation procedure indicated that viability of corneal epithelial and Chang cells treated with the PEG/PG/HP-guar product was significantly greater than viability of cells treated with the tear product without HP-guar or the tear products containing BAC or CMC/Purite®. Conclusions. The tear product containing HP-guar, PEG 400 and propylene glycol satisfies several pre-clinical criteria for an appropriate artificial tear formulation. It gives long-term desiccation protection of the intact cornea and also epithelial cells in culture and has no apparent deleterious affects on cells. It also provides conditions in which a damaged corneal epithelium can recover normal barrier function. The combination of ingredients in the formulation appears to provide an effective mucomimetic artificial tear product. These pre-clinical data suggest that the product will be effective in providing superior relief for the dry eye sufferer.

Técnica da instilação de colírios em pacientes portadores de glaucoma crônico

PURPOSE: To observe eye drop instillation technique in chronic glaucoma patients. METHODS: This is a prospective study enrolling 193 glaucomatous patients. Each received a sample of lubricant eye drop bottle (Dunason®, Alcon Laboratories, Sao Paulo, Brazil) and was instructed to use it once. RESULTS: All patients used a mean amount of 1.64 ± 1.26 drops. In 54.5% of the patients, the eyedropper touched the eye and adnexa. In 3.1% the drops were not placed in the eye, without the patient being aware of this. In 87.0% of them, neither the lacrimal point occlusion nor the closure of the eyes for two minutes after instillation were observed, and 61.6% repeatedly blinked right after instilling the drop. CONCLUSIONS: Most patients did not use the eye drops properly. That may result in some undesirable consequences, such as, a partial wastage of the bottle's content, a possible increase in systemic toxicity, the risk of contamination of the bottletip, and, mainly, a decrease in the full hypotensive effect of the drugs. Therefore, the patients have to be carefully taught the correct way to use eye drops.

Comparison of the clinical efficacy and comfort of olopatadine hydrochloride 0.1% ophthalmic solution and nedocromil sodium 2% ophthalmic solution in the human conjunctival allergen challenge model

Background: Mast cell stabilizers, such as the ocular antiallergic agent nedocromil sodium 2% ophthalmic solution, are not rapid acting and often require a loading period of ≥2 weeks for maximal efficacy. Olopatadine hydrochloride 0.1% ophthalmic solution is a member of a new class of topical antiallergic agents that have combined antihistaminic and mast cell-stabilizing properties. Objective: The purpose of this study was to compare the clinical efficacy and comfort of olopatadine with those of nedocromil in the conjunctival allergen challenge model. Methods: This was a single-center, 3-visit, randomized, double-masked, contralaterally controlled study. Seventy-five subjects with a history of allergic conjunctivitis were screened, and the 52 who responded to conjunctival allergen challenge at visits 1 and 2 were randomized by eye to receive olopatadine, nedocromil, or placebo (a “natural tears” lubricant eye drop). Because nedocromil may require a 2-week loading period for maximal efficacy, the eyes assigned to that agent received nedocromil for 14 days (between visits 2 and 3), whereas the eyes assigned to olopatadine or placebo received placebo during this period. Throughout the loading phase, subjects instilled 1 drop of the assigned masked medication in each eye twice daily. At the assessment visit (visit 3), subjects received 1 drop of masked olopatadine, nedocromil, or placebo in each eye and were asked to rate the comfort of each drop on a scale from 0 to 8. Fifteen minutes after instillation of medication, subjects were challenged with the allergen concentration that had elicited a positive conjunctival allergic response at the previous visits. Subjects then scored their itching on a scale from 0 to 4 at 3, 5, and 10 minutes after challenge. Mean itching scores for all eyes were compared by treatment. Paired t tests were performed on the mean itching and ocular comfort scores at each time point. At the end of the study, subjects were asked which treatment they preferred in terms of comfort and efficacy. Results: Forty-nine subjects completed the study. Forty eyes received olopatadine, 36 received nedocromil, and 22 received placebo. Olopatadine was clinically and statistically superior to nedocromil at reducing itching in the conjunctival allergen challenge model (mean unit difference: −1.60 at 3 minutes, −1.68 at 5 minutes, −1.19 at 10 minutes; P < 0.001). One drop of olopatadine was more efficacious than 29 drops of nedocromil. Olopatadine-treated eyes were rated as being significantly more comfortable than nedocromil-treated eyes (0.73 vs 1.55; P = 0.034). Of the 14 subjects treated with olopatadine and nedocromil who stated a preference, 10 (71%) were more satisfied with olopatadine than with nedocromil. Conclusion: In the conjunctival allergen challenge model, olopatadine was more efficacious and comfortable than nedocromil in reducing the itching associated with allergic conjunctivitis.