Liposomal Spray Research Articles

Provocation of the ocular surface to investigate the evaporative pathophysiology of dry eye disease

PurposeTo investigate whether standard clinical measures of tear film stability, meniscus height and symptomology reflect changes in evaporation rate induced by ocular surface provocations. MethodsForty participants (23.8 ± 4.5 years, 53 % female) with healthy to mild dry eyes underwent two tear film provocations in random sequence on separate occasions: playing a tablet computer high concentration game (http://slither.io/) for 30 min; and receiving treatment with humidity goggles for 10 min followed by liposomal spray application. Measures at baseline and 30 min later were: Symptom Assessment iN Dry Eye (SANDE) questionnaire, tear film lipid layer thickness (LLT), non-invasive tear film break-up time (NIBUT), tear meniscus height (TMH), dynamic tear film lipid layer pattern (DLP) and tear film evaporation (TFE). ResultsThere were no differences in the baseline measurements before each provocation (p > 0.05). Dry eye symptoms significantly worsened with concentration task (p < 0.001) and improved with treatment (p < 0.001). DLP and LLT significantly increased with treatment (p < 0.05), but was unaffected with the concentration task (p > 0.05). NIBUT declined with the concentration task (p = 0.015), but was not enhanced with treatment (p = 0.142). TMH increased after treatment (p = 0.001) and decreased with the concentration task (p = 0.006). While evaporation decreased with the concentration task (p < 0.001), treatment had no effect (p = 0.333). LLT was associated with evaporation (p = 0.036) and additionally with symptom severity (p = 0.002) and tear volume (p = 0.017). ConclusionsSub-classifying dry eye based on an ‘evaporative’ component to inform treatment seems over-simplistic. However objective TMH, NIBUT and LLT seem to be the key clinical metrics that drive ocular comfort.

Response Surface Optimization and In-vitro Evaluation of Sustained Release Topical Insulin Liposomal Spray for Wound Healing

Response Surface Optimization and In-vitro Evaluation of Sustained Release Topical Insulin Liposomal Spray for Wound Healing

Comparison of treatment effect across varying severities of meibomian gland dropout

Better understanding of the pathophysiology of meibomian gland dysfunction (MGD) has provided the opportunity to develop treatments which could be tailored for specific presentations of MGD. This study sought to directly compare treatment effectiveness for three current therapies across differing levels of MG dropout. Subjects (n=81), grouped by infrared meibography dropout proportions, into either no (control), mild, or pronounced MG dropout, were randomised to receive treatment with a latent heat device (n=25), liposomal spray (n=28), or heated warm compress (n=28). A battery of tear film measures was performed, pre- and post-application of treatment, and compared by treatment type and MG severity. Symptoms correlated with MG dropout proportions (r=0.618, p<0.001). Following treatment, non-invasive tear breakup time improved (p=0.010), independent of treatment type (p=0.131). The improvement was significant only in the pronounced MGD group (+4.32 ±1.15s, p=0.008), however, following treatment, the mild group was no longer distinct from the control group (p=0.843). Lipid layer grade (LLG) also improved following treatment (p<0.009), but again was not specific to treatment type (p=0.349). All three severity groups showed an improvement in LLG, with 49.3% of participants showing an improvement of at least one grade, and none showing decreased LLG. Increased LLG across all three treatment groups suggests that all methods increase meibum outflow to the tear film, resulting in a thicker lipid layer after treatment. These results suggest that all three treatments are effective in improving tear film quality, independent of MGD severity based either on symptoms or based on gland dropout.

Effect of lipid-based dry eye supplements on the tear film in wearers of eye cosmetics.

To compare the effects on tear film parameters and contamination in cosmetic eyeliner wearers, after single application of two lipid-based dry eye treatments: a lipid-containing lubricant eye drop and a phospholipid liposomal spray. Fifty participants were enrolled in a prospective, randomised, paired-eye, investigator-masked trial. Pencil eyeliner (Body Shop® Crayon Eye Definer) was applied to the upper eyelid periocular skin of both eyes, anterior to the lash line. Baseline tear film quality was assessed fifteen minutes after eyeliner application. A lubricant drop (Systane® Balance) was then applied to one eye (randomised), and liposomal spray (Tears Again®) to the contralateral eye. Tear film contamination, lipid layer grade, non-invasive tear film break-up time and tear evaporation rate were evaluated fifteen minutes post-treatment and compared to pre-treatment values. Pre-treatment measurements did not differ between eyes assigned to lubricant drop and liposomal spray. Tear film contamination was observed in a greater proportion of eyes following both treatments (both p<0.05), with no significant difference between treatments (p=0.41). Both treatments improved lipid layer thickness (both p≤0.01), but effected no significant change in non-invasive tear film break-up time or tear evaporation rate (all p>0.05). Changes in tear film parameters did not differ between treatments (all p>0.05). Both the lipid-containing lubricant eye drop and phospholipid liposomal spray result in clinically apparent tear film contamination in eyeliner cosmetic wearers. Although both treatments effected an increase in lipid layer thickness, neither displayed clinical efficacy in improving tear film stability.

Lipid Supplements and Clinical Aspects of Tear Film in Habitual Lens Wearers.

To establish the effect of lipid supplements on the tear lipid layer and their influence on lens wear comfort in habitual lens wearers. Forty habitual soft contact lens wearers were recruited to a double-masked, randomized crossover trial. An emulsion drop containing phosphatidylglycerine (Systane Balance; Alcon) and a saline drop as a placebo or a liposomal spray containing phosphatidylcholine (Tears again; BioRevive) and a saline spray as a placebo were used three times a day for 2 weeks with 48 hours washout between each intervention. Ocular comfort, lipid layer grade, and stability of the tear film using a Tearscope and tear evaporation rate using a modified VapoMeter were assessed after 6 hours of lens wear with lenses in situ. Neither of the lipid supplements improved lens wear comfort compared to baseline. The noninvasive surface drying time significantly reduced with the placebo spray at day 1 (P = .002) and day 14 (P = .01) whereas the lipid spray had no effect. With the lipid drop and placebo, noninvasive surface drying time was unchanged compared to baseline (P > .05) on day 1, but by day 14, noninvasive surface drying time was reduced with the lipid drop (P = .02) and placebo (P < .001). Symptomatic wearers showed shorter noninvasive surface drying time compared to asymptomatic wearers with the spray treatment on both days (P = .03) but not with the lipid drop (P = .64). The placebo drop significantly changed the lipid layer distribution (P = .03) with a higher percentage of thinner patterns compared to the baseline distribution at day 14. A weak but significant correlation was shown between ocular comfort and noninvasive surface drying time (r = -0.21, P = .003) and tear evaporation rate (r = 0.19, P = .008). Ocular comfort was not associated with lipid layer patterns (r = 0.13, P = .06). Ocular comfort during contact lens wear improved with increased tear film stability and a reduced tear evaporation rate. However, the lipid supplements did not improve ocular comfort from baseline.

LIPOSOMES: DRUG DELIVERY SYSTEM OR POSSIBLE DOPING AGENT?

The use of liposomes as drug delivery vehicle for treatment of various diseases is well known in medical field but its possible role as a masking agent in sports came into light when Liposom Forte® was found stored together with banned and non-banned drugs during investigations carried out by Italian legal authorities and recent availability of IGF-1 Liposomal Spray on internet. Role of liposomes as masking agent for anabolic steroids in the field of doping has been investigated by Botre et al. The aim of the present work was to study the effect of different parameters like temperature, pH, charge, time, concentration etc. on the interaction of liposomes and doping agents and to identify a possible marker for detection of their abuse in sports. The results showed that out of variety of doping agents, the direct addition of liposomes to urine samples containing anabolic steroids shows strong tendency to interact with the liposomes which results in the reduced concentration of the compound in the sample. However, there was no significant effect of temperature and incubation time on the interaction of liposome and doping agents while other parameters such as charge and concentration of liposome affect the interaction capacity. Keywords: WADA, Liposomes, DopingÂ

Comparison of the Clinical Efficacy of Four Different Liposomal Sprays for the Treatment of Dry Eye

Purpose: To compare the clinical efficacy of four different liposomal sprays for dry eye treatment. Methods: Prospective randomized consecutive intraindividual comparison enrolling 166 patients (age, 18 - 93 years). Patients were randomly assigned to one of 4 groups, receiving one spray in their right eye and another one in their left eye: Ocuvers Hyaluron (OH) (87 eyes) and Ocuvers Lipostamin (OL) (80 eyes) (Innomedis AG), and Tears Again (TA) (80 eyes) and Tears Again Sensitive (TAS) (85 eyes) (Optima Pharmaceutical). Symptomatology was evaluated with the OSDI (Ocular Surface Disease Index) questionnaire. Subjective comfort, tear break up time (TBUT), redness, tear meniscus, application comfort and smell were evaluated during a 30-minute follow-up. Results: Smell for TA and TAS was significantly fattier compared to OH and OL (p Conclusions: The four evaluated liposome sprays may be useful for dry eye treatment, with higher subjective comfort and less dry eye signs using the Ocuvers sprays. The use of OL may be a better treatment option for severe dry eye.

Compatibility of phospholipid liposomal spray with silicone hydrogel contact lens wear.

To assess the effects of two weeks of regular phospholipid liposomal spray application on lipid layer grade, tear film stability, subjective comfort, visual acuity, and lipid deposition in silicone hydrogel contact lens wearers. Thirty-one existing contact lens wearers were enrolled and fitted with two week planned replacement silicone hydrogel contact lenses (Acuvue® Oasys®) in a prospective, randomized, paired-eye, investigator-masked trial. A phospholipid liposomal spray (Tears Again®) was applied to one eye (randomized) four times daily for two weeks. LogMAR high contrast visual acuity (VA), low contrast glare acuity (LCGA), non-invasive tear film break-up time (NIBUT), and lipid layer grade (LLG) were measured at baseline and day 14, in both treated and control eyes. Subjective comfort relative to baseline, and spectrofluorophotometric assessment of contact lens surface lipid deposition were also assessed on day 14. All measurements did not differ at baseline between treated and control eyes. Lipid layer thickness and tear film stability were increased on day 14 in treated eyes (all p<0.05), but not in control eyes (all p>0.05). A greater proportion of participants reported improved comfort in the treated eye relative to the control eye (p=0.002). There were no significant differences in visual acuity or in contact lens surface lipid deposition, between treated and control eyes, on day 14 (all p>0.05). The phospholipid liposomal spray increased tear film stability, lipid layer thickness and subjective comfort in silicone hydrogel contact lens wearers, without adversely affecting visual acuity or contact lens surface lipid deposition.

Effects of Lipid Supplements on Tear Biochemistry in Contact Lens Wearers.

To establish the effect of lipid supplements on tear lipid biochemistry and their influence on lens wear comfort in habitual lens wearers. Forty habitual soft contact lens wearers were recruited to a double-masked, randomized crossover trial. An emulsion drop containing phosphatidylglycerol (Systane Balance; Alcon) and a liposomal spray containing phosphatidylcholine (Tears again; BioRevive) along with saline placebos were used three times a day for 14 days with 48 hours of washout between each intervention. The Contact Lens Dry Eye Questionnaire categorized participants into symptomatic and asymptomatic wearers. Ocular comfort was measured using the Ocular Comfort Index. Basal tears (15 μl from each eye) were collected with lenses in situ and assayed for the concentration and activity of phospholipase (sPLA2) and the concentration of a malondialdehyde (MDA). Electrospray ionization mass spectrometry characterized the tear lipidome. Neither of the lipid supplements improved lens wear comfort compared to baseline. The spray treatment did not affect the concentration of the majority of lipid classes either at day 1 or at day 14. Both the lipid and placebo drops resulted in increased concentration of several lipid classes after day 1 of use, but by day 14, the concentration of most of the lipid classes had returned to baseline levels. With the lipid spray, sPLA2 activity (0.38 ± 0.2 vs. 0.73 ± 0.6 mmol/min/ml, p = 0.03) and lysophosphatidylethanolamine (LPE) (1.3 ± 0.5 vs. 2.7 ± 0.07 pmol/μl, p = 0.02) were higher in the symptomatic group compared to asymptomatic group at day 1 but not at day 14. The lipid drop resulted in increased LPE concentration in symptomatic wearers at day 1 (1.7 ± 0.3 vs. 2.4 ± 0.3 pmol/μl, p = 0.01) and at day 14 (1.7 ± 0.4 vs. 2.5 ± 0.5 pmol/μl, p = 0.04). Ocular comfort was inversely proportional to the level (r = -0.21, p = 0.007) and activity of sPLA2 (r = -0.20, p = 0.01). There was an association between sPLA2 and LPC (r = 0.41, p < 0.001) and LPE (r = 0.40, p = 0.001), and a negative association with (O-acyl)-ω-hydroxy fatty acids (OAHFAs) (r = -0.30, p = 0.03) in tears. Contact lens wear comfort was associated with sPLA2 concentration and activity in tears. Lipid biochemistry was transiently influenced by exogenous supplements. Although the specific supplement formulations tested did not differ from placebo in this study, the results do suggest a potential role for lysophospholipids and OAHFAs in modulating symptoms during contact lens wear.

Dry Eye Disease: Present Challenges in the Management and Future Trends.

Dry eye disease (DED) is a tear film disorder resulting in hyperosmolarity of the tear film and inflammation of the ocular surface. DED is also referred to as keratoconjunctivitis sicca (KCS) and dry eye syndrome. DED represents a significant public health issue, particularly in older adults, and needs more research and attention. Despite the urgent need for safe and effective pharmacotherapies, there is currently only one approved medication, Restasis®, to tackle DED. In this review article, we present an overview of DED, classification, epidemiology, pathophysiology, diagnosis, and risk factors of DED. Special emphasis is placed on current treatment options for DED such as artificial tears, lipid-containing lubricants, liposomal spray, inserts, anti-inflammatory or immunosuppressant drops, antibiotics, dietary omega-3 essential fatty acids, autologous serum, intense-pulsed-light (IPL), punctual plugs, moisture-retaining eyeglasses, hydrophilic bandage contact lenses and secretagogues. The review also summarizes trends in DED treatment that are patented and are currently under investigation in clinical trials.

Understanding the benefits of liposomal eye sprays for dry eye patients

Understanding the benefits of liposomal eye sprays for dry eye patients

Clinical and biochemical tear lipid parameters in contact lens wearers.

Alterations in tear film lipids may be important in modulating discomfort during contact lens wear. This study investigates associations between clinical and biological components of the lipid layer and seeks to determine the effect of lipid supplementation on contact lens wear comfort. Participants were grouped into symptomatic (n = 10) and asymptomatic (n = 10) contact lens wearers according to the Contact Lens Dry Eye Questionnaire. After 6 hours of lens wear, noninvasive surface drying time (NISDT) and the lipid layer grade were assessed using a Tearscope. Basal tears were collected using a microcapillary tube and assayed for concentration and activity of the secretory phospholipase A2 enzyme and concentration of the lipid aldehyde malondialdehyde. Mass spectrometry was used to characterize the tear lipidome. In the second phase, a liposomal spray (Tears Again, BioRevive) or a saline spray was sprayed over the upper eyelids of each subject during their down gaze and during lens wear. Noninvasive surface drying time and ocular comfort were obtained soon after spraying and again at 2 and 6 hours after the initial spray. Statistical tests included the Student t test, repeated-measures analysis of variance, and the Pearson correlation test where appropriate. Noninvasive surface drying time was lower (p = 0.01) in symptomatic (4.5 ± 0.6 seconds) than in asymptomatic (9.9 ± 3.1 seconds) contact lens wearers. The mole percentage of wax esters in the total lipidome increased with NISDT (R = 0.70, p = 0.01). Secretory phospholipase A2 enzyme activity in tears was associated with higher levels of malondialdehyde (R = 0.65, p = 0.01) and shorter NISDT (R = 0.84, p = 0.001). Noninvasive surface drying time reduced over the time course for the saline spray (p = 0.01) but did not reduce until the 6-hour time point with the liposomal spray. With liposomal spray, NISDT was higher (p = 0.03) immediately after instillation compared with 6 hours later (9.5 ± 1.9 vs. 5.2 ± 2.1 seconds). A longer NISDT was associated with improved ocular comfort for those using the liposomal spray (R = 0.25, p = 0.005) but not with saline. Degraded lipids and a lower mole percentage of wax esters in the tear film may be associated with a lower NISDT. Lipid supplements may improve ocular comfort during lens wear by increasing NISDT.

Changes of inflammatory cytokines and tear osmolarity in systemic sclerosis after treatment with liposomes sprayed

AbstractPurpose To investigate the effect of treatment with a liposomal spray solution in patients with systemic sclerosis (SSc) and severe dry eye by measuring the levels of inflammatory cytokines and tear osmolarity.Methods Twenty‐two subjects (12M, 10F) aged 45.1+/‐7.1 years participated in this prospective, randomised, double‐masked investigation. DES was identified in patients with SSc according to the classification of Dry Eye Disease of International Dry Eye Workshop (2007) and tear osmolarity values (TearLab system) according to recommendations of the manufacturer with a cutoff value of 308 mOsm/L (3). Liposomal spray (nebulized, two sprays each, on the eyelids, 3 times per day for 3 weeks) with vitamin A and E was applied to one eye, and an equal volume of saline spray (control) applied to the contralateral eye. Non‐invasive tear film stability (NIBUT), osmolarity and inflammatory cytokines (IL‐1β, IL6, TNF‐α,IFN‐γ) were evaluated at baseline, and at 5, 10, 15 days after spray solution application.Results A highly significant reduction (p&lt;0.01‐0.001) was detected in the inflammatory cytokine levels and osmolarity in tears of eye treated with the spray liposomes solution in comparison with fellow eye treated with sprayed saline solution. There were significant differences among the 2 eyes concerning tear osmolarity (p &lt; 0.001) and TBUT (p &lt; 0.05) scores.Conclusion This study showed the ability of liposomal spray application to modify the pro‐inflammatory cytokine profile and to increase stability characteristics of the pre‐ocular tear film in severe dry eye of SSc patients.This effect could be due to the anti‐inflammatory mechanism of the vitamins and also to the barrier effect of liposomes.

Innovative treatments for MGD ‐ EVER more important for ocular surface disease

AbstractThe 2011 TFOS MGD Report has translated into several new developments in the therapy of Dry Eye Disease with a focus on MGD. Lipid supplementation is recognized as crucial for dry eye therapy either as liposomal spray or in many new tear substitutes. Physical therapy is recognized as a causative treatment in order to re‐liquify inspissated secretum before the application of mechanical pressure in order to eventually release obstructed glands. Since the application of adequate heat is time consuming and tricky, pre‐heated gel applicators or controlled heating googles can be used but must still be repeated every day. Even then, manual expression of the multitude of meibomian glands can be painful or ineffective. A new automated device that allows the computer controlled application of heat and pressure under the supervision of the ophthalmologist in his practice presently occurs as the most advance and effective therapy option that can lead to longterm restoration of meibomian gland function over several months. Azithromycin, a new topical drug has, besides a long‐term tissue uptake, not only an antibiotic but also an anti‐inflammatory and a newly observed promotive effect on gland function and is widely used for MGD.

Photodynamic therapy using a new formulation of 5-aminolevulinic acid for wrinkles in Asian skin: A randomized controlled split face study

Background: Photodynamic therapy (PDT) with intense pulsed light (IPL) was proven effective for photorejuvenation. Recently, a new formulation of 0.5% 5-aminolevulinic acid (ALA) liposomal spray has been available. We designed a randomized split face study to evaluate usefulness and safety of IPL-PDT using a liposomal spray for periorbital wrinkles in Asians.Methods: Patients received three treatments every 3 weeks. The half of the face was treated with IPL-PDT and the other half with long pulsed Nd:YAG laser (LPNY). Skin fluorescence was measured using a spectrophotometer for the guidance of PDT treatment. Wrinkle score was marked by two-blinded independent dermatologists.Results: One patient dropped out due to 3-d lasting erythema on PDT side. The difference of mean reduction in lower and lateral periorbital wrinkle score on PDT side between the first and the last visit was statistically significant (p = 0.008 and p = 0.001, respectively). Lateral periorbital wrinkles treated with PDT showed better results than LPNY-treated sides. Twenty-five percent of patients reported good to excellent outcomes.Conclusion: This study demonstrated that PDT with a liposomal spray provided modest wrinkle reduction without serious adverse effect and it might be a promising treatment modality for wrinkle treatment in Asians.

Effect of nasal sprays on an in vitro survival and morphology of nasoseptal cartilage.

Nasal sprays were introduced several years ago to support the treatment of allergic rhinitis. These sprays may come in direct contact with directly exposed nasoseptal cartilage (e.g. is case of nasoseptal perforation). To date, no studies investigated the effects of nasal sprays on cartilage tissues and cells. Therefore, our aim was to analyze the influence of two different nasal spray types (thixotropic and liposomal) on the vitality of nasoseptal chondrocytes. Human chondrocytes were isolated from surgically dissected tissues. Alternatively, nasal septa (porcine and human) tissue explants were used. The cell or explant cultures were treated with nasal sprays for 4-24h. As a read-out, cell vitality and gene and protein expression profiles of type I and II collagen, SOX 9 and matrix metalloproteinase MMP-1 were compared to the untreated controls by means of real-time RT-PCR and immunostaining. Using the liposomal, but not thixotropic nasal spray in an explant or chondrocyte in vitro culture led to increased cell death, as compared to the untreated controls. A trend towards suppression of type II collagen and SOX 9 on protein level was found in cultures exposed to liposomal nasal spray, as compared to the controls. The thixotropic nasal spray has not affected the nasoseptal chondrocytes. Further studies with the use of viable nasoseptal cartilage explants and particularly using an in vivo animal model of exposed nasoseptal cartilage are necessary to clear the effect of liposomal spray on chondrocytes.

Effect of three different liposomal eye sprays on ocular comfort and tear film

Effect of three different liposomal eye sprays on ocular comfort and tear film

Efficacy and tolerability of 5-aminolevulinic acid 0.5% liposomal spray and intense pulsed light in wrinkle reduction of photodamaged skin

Background: Photodynamic therapy (PDT) with 5-aminolevulinic acid (5-ALA) is effective for the treatment of photoaging. Objective: To evaluate the efficacy and safety of PDT using a novel 0.5% liposome-encapsulated 5-ALA spray and an intense pulsed light (IPL) system (Ellipse Flex PPT) in reduction of periorbital and nasolabial wrinkles. Patients and Methods: Thirty healthy volunteers, aged 35–65 years, skin type I–III, with type 2 photoaging underwent a baseline visit, three ALA-IPL treatments once every 3 weeks, an end-of-treatment visit and a final visit 3 months after the end-of-treatment visit. Wrinkle depth was evaluated according to the modified Fitzpatrick wrinkle scale (MFWS). At the final visit, patients rated their degree of overall improvement. Results: For periorbital and nasolabial wrinkles, the differences of the average MFWS evaluation between baseline versus end-of-treatment visit, baseline versus final visit and end-of-treatment visit versus final visit were statistically significant (p < 0.001). The average overall improvement was greater for periorbital than for nasolabial wrinkles (p < 0.001). No side effects were observed during and after treatment. The degree of overall improvement was scored as excellent by 47% of the volunteers. Conclusions: ALA-IPL treatment using 0.5% liposome-encapsulated 5-ALA spray and Ellipse Flex PPT system is effective and safe for the treatment of type 2 photoaging reducing the PDT-associated side effects.

Photodynamic therapy of acne vulgaris using 5‐aminolevulinic acid 0.5% liposomal spray and intense pulsed light in combination with topical keratolytic agents

Increasing antibiotic resistance of Propionibacterium acnes and growing awareness on the side effects of topical and systemic drugs in the treatment of acne vulgaris by physicians and patients have paved the way for a search into new efficacious and safe treatment modalities such as photodynamic therapy (PDT). Although the efficacy of PDT using 20% 5-aminolevulinic acid (ALA) cream has been established, phototoxic side effects limit its use. The 5-ALA concentration can be lowered by a factor of 40 by changing the vehicle of 5-ALA from a moisturizing cream to liposome encapsulation. Assessment of the efficacy and the safety of PDT using 5-ALA 0.5% in liposomal spray and intense pulsed light (IPL) in combination with topical peeling agents (Li-PDT-PC) in acne vulgaris. 32 patients suffering from acne participated in this randomized, prospective, single blind study. All patients were treated with Li-PDT-PC. During the study nine patients were additionally treated with topical or systemic antibiotics (Li-PDT-PC-AT). These patients were removed from the study although their results were recorded. Results After a mean period of 7.8 months and a mean number of 5.7 treatments the mean total number of lesions dropped from 34.6 lesions to 11.0 lesions, resulting in a mean improvement of 68.2%. Side effects were minimal. Additionally, an intention to treat analysis was conducted. Photodynamic therapy of acne vulgaris using 5-ALA 0.5% liposomal spray and IPL in combination with topical peeling agents is safe and efficacious, even in patients with acne recalcitrant to standard therapy.

Effect of a liposomal spray on the pre-ocular tear film

With the potential to address evaporative dry eye, a novel spray has been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid. This study evaluated the short-term effects of liposomal spray application on the lipid and stability characteristics of the pre-ocular tear film in normal eyes. Twenty-two subjects (12M, 10F) aged 35.1+/-7.1 years participated in this prospective, randomised, double-masked investigation in which the liposomal spray was applied to one eye, and an equal volume of saline spray (control) applied to the contralateral eye. Lipid layer grade (LLG), non-invasive tear film stability (NIBUT) and tear meniscus height (TMH) were evaluated at baseline, and at 30, 60, 90 and 135min post-application. Subjective reports of comfort were also compared. Treated and control eyes were not significantly different at baseline (p>0.05). Post-application, LLG increased significantly, at 30 and 60min, only in the treated eyes (p=0.005). NIBUT also increased significantly in the treated eyes only (p<0.001), at 30, 60 and 90min. TMH did not alter significantly (p>0.05). Comfort improved relative to baseline in 46% of treated and 18% of control eyes, at 30min post-application. Of those expressing a preference in comfort between the eyes, 68% preferred the liposomal spray. Consistent with subjective reports of improved comfort, statistically and clinically significant improvements in lipid layer thickness and tear film stability are observed in normal eyes for > or =1h after a single application of a phospholipid liposomal spray.