Ophthalmic Suspension Research Articles

Novel Sustained-Release Drug Delivery System for Dry Eye Therapy by Rebamipide Nanoparticles.

The commercially available rebamipide ophthalmic suspension (CA-REB) was approved for clinical use in patients with dry eye; however, the residence time on the ocular surface for the traditional formulations is short, since the drug is removed from the ocular surface through the nasolacrimal duct. In this study, we designed a novel sustained-release drug delivery system (DDS) for dry eye therapy by rebamipide nanoparticles. The rebamipide solid nanoparticle-based ophthalmic formulation (REB-NPs) was prepared by a bead mill using additives (2-hydroxypropyl-β-cyclodextrin and methylcellulose) and a gel base (carbopol). The rebamipide particles formed are ellipsoid, with a particle size in the range of 40–200 nm. The rebamipide in the REB-NPs applied to eyelids was delivered into the lacrimal fluid through the meibomian glands, and sustained drug release was observed in comparison with CA-REB. Moreover, the REB-NPs increased the mucin levels in the lacrimal fluid and healed tear film breakup levels in an N-acetylcysteine-treated rabbit model. The information about this novel DDS route and creation of a nano-formulation can be used to design further studies aimed at therapy for dry eye.

Novel Long Retentive Posaconazole Ophthalmic Suspension

Ophthalmic formulations are not completely available for eliciting therapeutic action because of various reasons such as rapid tear drainage, blinking of eye, lower residence time and lower cul de sac volume. Ophthalmic formulation gets easily drained off due to eye blinking due to low viscosity. Posaconazole is known to have antifungal efficacy as oral route, however ophthalmic efficacy is not studied. The objective of present work was to develop long retentive posaconazole ophthalmic suspension based on polymer platform system of carbopol 974 P and xanthan gum. This synergistic polymer platform was pre-identified by means of experimental design study. Polymer based formulation helps to retain the drug at the site of action for longer duration and does not get washed away due to eye blinking phenomenon. Sterilization is key parameters for ophthalmic formulation. Different methods of sterilization were studied for posaconazole drug as well as polymer mixture and finished product. The developed formulations were characterized for homogeneity, pH, particle size, viscosity, osmolality, rheology study, mucoadhesive strength, contact angle, assay of posaconazole and benzalkonium chloride, degradation product, polymorphic form evaluation, eye irritation test and pharmacodynamic efficacy study. A stable long retentive posaconazole ophthalmic formulation was developed based on principles of quality by design. The developed formulation can be easily manufactured at bigger scale without need of any sophisticated equipment.

Clinical translation of eye drops and complex drug products

AbstractEye drops constitute majority of ophthalmic drug products, with solutions, suspensions, ointments, and emulsions being the top formulations. While solutions are considered simple formulations, with biowaiver granted for qualitatively and quantitatively similar generic formulations, others are complex formulations, whose generic products are difficult to develop and translate. In particular, manufacturing processes as well as the grades of inactive ingredients used can affect drug product attributes and bioavailability. Thus, bioequivalence of complex generics is less certain. The US FDA issued some draft guidance documents to ease approval of complex generic drug products. One purpose of this presentation is to discuss the difficulties in clinical translation of complex generic eye drop products. In recent years, there has been significant effort in developing eye drops for back of the eye drug delivery, using either pure drug formulations or carrier‐drug composite formulations (e.g., polymeric nanoparticles), with little or no success to date. The second purpose of this presentation is to discuss translational gaps in advancing eye drops for back of the eye drug delivery and to further discuss the difficulties in manufacturing and stabilizing composite nanoparticle formulations for eye drop applications.

Role of 2% rebamipide ophthalmic suspension in the management of dry eye disease

Role of 2% rebamipide ophthalmic suspension in the management of dry eye disease - IJCEO- Print ISSN No: - 2395-1443 Online ISSN No:- 2395-1451 Article DOI No:- 10.18231/j.ijceo.2019.110, Indian Journal of Clinical and Experimental Ophthalmology-Indian J Clin Exp Ophthalmol

An Evaluation of Staphylococci from Ocular Surface Infections Treated Empirically with Topical Besifloxacin: Antibiotic Resistance, Molecular Characteristics, and Clinical Outcomes.

IntroductionUnderstanding antibiotic resistance and toxin profiles among staphylococcal isolates in ocular infections can aid in therapeutic management and infection prevention strategies. We evaluated in vitro antibiotic resistance patterns and molecular traits of staphylococci isolated from patients with ocular surface infections. We also report on clinical outcomes for these patients following empirical treatment with topical besifloxacin ophthalmic suspension 0.6%.MethodsThis was a small observational study. Participating investigators from three clinical sites collected an initial ocular culture from the affected eye of patients presenting with ocular surface infections with presumed staphylococcal etiology. Clinical outcome data for patients with confirmed staphylococcal infections were collated later through retrospective review of patient medical records. Staphylococcal species identification in ocular cultures, in vitro antibiotic susceptibility testing, and PCR-based determination of methicillin resistance cassettes and toxin genotypes were conducted at a central laboratory. Isolates were categorized as susceptible or resistant based on systemic breakpoints, where available.ResultsCultures were collected from 43 patients, and staphylococcal infections were confirmed in 25 patients. Two isolates of Staphylococcus aureus and 27 isolates of Staphylococcus epidermidis were identified. Both S. aureus isolates were methicillin-susceptible, lacked the gene encoding Panton-Valentine leukocidin, and carried few enterotoxin genes. Eight (30%) S. epidermidis were methicillin-resistant (MRSE), and 10 (37%) were ciprofloxacin-resistant. All but two MRSE isolates demonstrated multidrug resistance (MDR), and the staphylococcal cassette chromosome mec (SCCmec) type IVa was detected in five of the eight MRSE isolates. Clinical resolution of the ocular surface infection was reported in all 25 patients following treatment with besifloxacin.ConclusionsIn this study, S. aureus contained few toxins, while SCCmec IVa and MDR was predominant among MRSE from ocular surface infections. Despite significant in vitro fluoroquinolone resistance, there were no cases of treatment failure with topical besifloxacin ophthalmic suspension 0.6%.FundingBausch Health US, LLC.

Eye drop technique and patient-reported problems in a real-world population of eye drop users.

To assess eye drop technique and patient-reported problems with eye drop instillation in a primary care sample of eye drop users. Cross-sectional observational study in 136 community pharmacies in Belgium. Patient inclusion criteria were being age ≥ 18 years and using eye drops for ≥ 1 month (to ensure that patients were already familiar with eye drop instillation). Participants demonstrated their eye drop technique and completed a self-administered questionnaire. Participants (n = 678) had a mean age of 68.9 ± 12.4 years. During the demonstration, almost everyone (98.0%) successfully instilled at least one drop in the eye, although 14% required multiple attempts to achieve this. Only 3% of the sample exhibited perfect drop technique, meaning that they performed correctly all the steps. Most common deviations were touching the bottle to the eye or eyelid (40.7% of patients), and failing to close the eye (67.8%) and perform nasolacrimal occlusion for at least 1 min (94.7%) after drop instillation. Importantly, we found that 20% of ophthalmic suspensions were not shaken before use. Forty percent of patients reported ≥ 1 problem with eye drop instillation. Most common problems were difficulties with getting a drop in the eye (18.3% of patients), too many drops coming out of the bottle (14.6%), and difficulty squeezing the bottle (12.2%). About half of the sample recalled having had education in eye drop instillation technique. This study showed suboptimal eye drop technique in real-world clinical practice. A proactive role of community pharmacists in detecting and resolving these problems could be helpful.

Miniaturized turbidimetric assay: A green option for the analysis of besifloxacin in ophthalmic suspension

Besifloxacin is an important antimicrobial agent, belonging to the class of fluoroquinolones, used in the treatment of infectious conjunctivitis. Quality control of this active pharmaceutical ingredient is essential, since poor quality antimicrobials may contribute to the aggravation of the worrying picture of bacterial resistance. Thus, analytical methods need to be developed, validated and improved for that purpose. It is also important that these methods be environmentally friendly, as ensuring the quality of products without harming the environment meets the global needs. The aim of the study was the development and validation of a miniaturized turbidimetric microbiological method for the analysis of besifloxacin hydrochloride (BSF) in ophthalmic suspension. The analyzes were performed in 96-well microplates using Staphylococcus epidermidis ATCC 12228 as test microorganism and BHI broth. The method was validated according to ICH guidelines and showed to be linear (in a range of 0.5–8.0 μg mL−1), precise, accurate, robust and selective. Study of photo-degradation kinetics of BSF sample showed a zero order reaction. A comparative study with a previously validated HPLC method showed that the methods are interchangeable. This work shows the great potential of the proposed method of being introduced in routine analyzes of quality control of BSF in ophthalmic suspension as an option in line with the principles of Green Chemistry.

The effect of sodium hyaluronate eye drops on tear function after vitrectomy combined with silicone oil tamponade

Objective To observe the effect of sodium hyaluronate eye drops on tear function after vitrectomy combined with silicone oil tamponade. Methods A prospective study. Total of 52 eyes of 52 patients with rhegmatogenous retinal detachment who underwent vitrectomy combined with silicone oil tamponade from Nov. 2017 to Oct. 2018 were enrolled. The patients were randomly divided into clinical trial group and control group, with 26 cases in each group. The control group was given tobramycin and dexamethasone eye ointment and prednisolone acetate ophthalmic suspension, and the clinical trial group was given sodium hyaluronate eye drops on the basis of the control group. Results The tear film rupture time in clinical trial group at 3 and 7 days after operation were higher than that of the control group (P=0.046, 0.021). The dry eye symptom score of the clinical trial group was lower than that of the control group at 7 days after operation (P=0.029). Conclusion Sodium hyaluronate eye drops can effectively alleviate the dry eye symptoms of patients after vitrectomy, and recovery of tear film stability in early postoperative period. Key words: Vitrectomy; Dry eye; Tear film; Eye drops, sodium hyaluronate

Bromfenac Ophthalmic Solution 0.07% Versus Nepafenac Ophthalmic Suspension 0.3% for Post-Cataract Surgery Inflammation: A Pilot Study of Identical Dosing Regimens with Pre-Surgical "Pulse" Dose.

IntroductionThis small pilot study is the first direct comparison of the currently marketed formulations of bromfenac (0.07% solution) and nepafenac (0.3% suspension) using identical dosing regimens and including an extra pre-surgical “pulse” dose in patients undergoing cataract surgery.MethodsAdults scheduled for unilateral phacoemulsification with intraocular lens implantation were randomly assigned to bromfenac 0.07% or nepafenac 0.3%, each given once-daily 1 day prior to surgery, on the day of surgery plus an extra dose 1 h before surgery, and for 14 days after surgery. Assessments included summed ocular inflammation score (SOIS), visual acuity (VA), and retinal thickness measured via optical coherence tomography.ResultsThe study population included 49 patients (bromfenac, n = 24; nepafenac, n = 25). The percentage of patients with a SOIS = 0 (no cells or flare) at post-surgical day 15 (primary efficacy endpoint) was statistically similar between the bromfenac (57.1%) and nepafenac (50.0%) treatment groups (intent-to-treat with last observation carried forward) (P = 0.6318). The proportions of patients with an SOIS of 0 at days 3 and 8 were significantly (P < 0.05) higher in the bromfenac group (23.8 and 52.4%, respectively) versus the nepafenac group (0.0 and 20.8%, respectively). Visual acuity was similar between groups at each study visit, as were mean retinal thickness and change from baseline in retinal thickness. Rescue medication (typically difluprednate) was given on or before day 15 to 13 patients in each treatment group (bromfenac, 54.2%; nepafenac, 52.0%). There were no adverse events considered to be related to either treatment.ConclusionsThe results of this small pilot study suggest that once-daily bromfenac 0.07% produces similar benefits with regard to postsurgical inflammation, VA, and retinal thickness as once-daily nepafenac 0.3%, and possibly has a faster onset of anti-inflammatory action, when compared using identical dosing regimens.FundingBausch & Lomb Incorporated.Trial RegistrationNCT03886779.

To Study Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension

To Study Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension

Efficacy of postoperative medication in the treatment of cataract with uveitis

Objective To evaluate the efficacy of postoperative application of diclofenac sodium combined with triamcinolone acetonide in the treatment of cataract with uveitis. Methods The data of 85 patients of cataract with uveitis from Jan. 2016 to Jun. 2018 in Luhe Hospital were studied retrospectively.According to the random number table, all patients were divided into the observation group and the control group.The two groups were performed phacoemulsification and intraocular lens implantation.The control group, 40 cases, received injection of triamcinolone subconjunctival postoperatively, and treated with Tobramycin and Dexamethasone ophthalmic suspension eye drops after injection.The observation group, 45 cases, received diclofenac sodium eye drops on the basis of eyes drops of the control group.The course of medication was 1 month. The changes after treatment were compared between the two groups. Results The aqueous humor sCD44, TGF-β2 and MCP-1 in the observation group at 1 month after treatment were significantly better than those in the control group (P 0.05). In the observation group, the visual acuity, the incidence of grade 0 anterior chamber reaction, the total incidence of corneal edema, macular edema and photophobia were significantly better than those in the control group (P 0.05). Conclusion Application of Diclofenac sodium combined with triamcinolone acetonide is effective for cataract with uveitis, can reduce the aqueous humor sCD44, TGF-β2 and MCP-1 levels, alleviate anterior chamber reaction, and reduce the complications. Key words: Cataract; Uveitis; Phacoemulsification; Triamcinolone acetonide; Factor, aqueous humor

Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension.

Developing mathematical models to predict changes in ocular bioavailability and pharmacokinetics due to differences in the physicochemical properties of complex topical ophthalmic suspension formulations is important in drug product development and regulatory assessment. Herein, we used published FDA clinical pharmacology review data, in-house, and literature rabbit pharmacokinetic data generated for dexamethasone ophthalmic suspensions to demonstrate how the mechanistic Ocular Compartmental Absorption and Transit model by GastroPlus™ can be used to characterize ocular drug pharmacokinetic performance in rabbits for suspension formulations. This model was used to describe the dose-dependent (0.01 to 0.1%) non-linear pharmacokinetic in ocular tissues and characterize the impact of viscosity (1.67 to 72.9cP) and particle size (5.5 to 22μm) on in vivo ocular drug absorption and disposition. Parameter sensitivity analysis (hypothetical suspension particle size: 1 to 10μm, viscosity: 1 to 100cP) demonstrated that the interplay between formulation properties and physiological clearance through drainage and tear turnover rates in the pre-corneal compartment drives the ocular drug bioavailability. The quick removal of drug suspended particles from the pre-corneal compartment renders the impact of particle size inconsequential relative to viscosity modification. The in vivo ocular absorption is (1) viscosity non-sensitive when the viscosity is high and the impact of viscosity on the pre-corneal residence time reaches the maximum physiological system capacity or (2) viscosity sensitive when the viscosity is below a certain limit. This study reinforces our understanding of the interplay between physiological factors and ophthalmic formulation physicochemical properties and their impact on in vivo ocular drug PK performance in rabbits.

UV-Spectrophotometry – Multicomponent Mode of Analysis for Simultaneous Estimation of Brinzolamide and Brimonidine Tartrate in Bulk and Ophthalmic Formulation

Brinzolamide (BRZ) and Brimonidine Tartrate (BT) in combination are available as an ophthalmic suspension in the ratio of 5:1. A simple, reproducible and efficient method for the simultaneousdetermination of BRZ and BT in Bulk and Ophthalmic formulation has been developed. The absorbance was assessed at two wavelengths i.e. 252.40 nm (λ max of BRZ) and 246 nm (λ max of BT) in methanol. In this method, BRZ and BT executed linearity in the concentration range of 5-35 μg/mL and 3-18 μg/mL, respectively at their respective λ max. The developed method was found to be accurate, precise and rugged as marked by small values of % RSD according to ICH guidelines.

Retrospective Observational Study on Rebamipide Ophthalmic Suspension on Quality of Life of Dry Eye Disease Patients.

Purpose The Dry Eye-Related Quality-of-Life Score (DEQS) is a Japanese dry eye-specific questionnaire that has been used to assess the symptoms of dry eye and their effects on the quality of life (QOL) in Japanese individuals. The purpose of this study was to determine the effect of rebamipide (RBM) on the QOL of Japanese patients with dry eye disease (DED). Method The medical records of 43 patients (3 men and 40 women; mean age: 64 ± 14 years; range: 32 to 83 years), who were diagnosed with DED and treated with RBM at the Ehime University Hospital between November 2012 and June 2016, were reviewed. The effects of 2% rebamipide (RBM) ophthalmic suspension on the symptoms of DED was determined by the answers to the DEQS questionnaire and clinical findings. The clinical findings before and 1, 3, 6, 12, and 24 months after initiating the RBM treatment were reviewed. The following data were collected from the DEQS: the Summary score and two subscale scores, the Bothersome ocular symptoms score, and the Impact on daily life score. In addition, the standard fluorescein staining score, the Schirmer I test score, and the tear breakup time (TBUT) score were analyzed. Result The Summary score and Impact of daily life score of the DEQS were improved significantly after 1, 3, 6, and 12 months of RBM, and the Bothersome ocular symptoms scores of the DEQS were also improved after 1, 3, and 6 months. The fluorescein staining scores were significantly decreased after 1, 3, 6, and 12 months, and the TBUT score was significantly increased after 1 month. Conclusion RBM treatment improves the QOL by alleviating the corneal and conjunctival epithelial damages. The DEQS is a useful questionnaire that can assess the severity of the DED symptoms and their impact on the QOL. This trial is registered with UMIN000024405.

Ocular anti-inflammatory activity of prednisolone acetate loaded chitosan-deoxycholate self-assembled nanoparticles.

Background and purpose: Conventional topical ophthalmic aqueous solutions and suspensions are often associated with low bioavailability and high administration frequency, pulsatile dose and poor exposure to certain ocular parts. The aim of this study was to develop an ophthalmic nanoparticles loaded gel, for delivering prednisolone acetate (PA), to increase dosing accuracy, bioavailability, and accordingly, efficiency of PA in treating inflammatory ocular diseases.Methods: A novel formulation of self-assembled nanoparticles was prepared by the complexation of chitosan (CS) and, the counter-ion, sodium deoxycholate (SD), loaded with the poorly-water-soluble PA. Particle size, zeta potential, encapsulation efficiency (EE) and drug loading content (LC) of prepared nanoparticles were assessed. Moreover, the nanoparticles were characterized using differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR). Drug release and eye anti-inflammatory potential of the prepared novel formulation was investigated.Results: Mean particle size of the nanoparticles have dropped from 976 nm ±43 (PDI 1.285) to 480 nm ±28 (PDI 1.396) when the ratio of CS-SD was decreased. The incorporation of 0.1-0.3% of polyvinyl alcohol (PVA), in the preparation stages, resulted in smaller nanoparticles: 462 nm ±19 (PDI 0.942) and 321 nm ±22 (PDI 0.454) respectively. DSC and FTIR results demonstrated the interaction between CS and SD, however, no interactions were detected between PA and CS or SD. Drug release of PA as received, in simulated tears fluid (pH 7.4), showed a twofold increase (reaching an average of 98.6% in 24 hours) when incorporated into an optimized nanoparticle gel formulation (1:5 CS-SD).Conclusion: The anti-inflammatory effect of PA nanoparticles loaded gel on female guinea pig eyes was significantly superior to that of the micronized drug loaded gel (P < 0.05).

Topical Tacrolimus for Chronic Allergic Conjunctival Disease with and without Atopic Dermatitis

ABSTRACTPurpose/Aim: This study evaluated the efficacy of topical 0.1% tacrolimus ophthalmic suspension for treating chronic allergic conjunctival disease with and without atopic dermatitis.Materials and Methods: This study was conducted as a prospective observational post-market survey. Our large-scale study protocol was accepted by the Pharmaceuticals and Medical Devices Agency in Japan and included patients who were prescribed topical tacrolimus for the treatment of chronic allergic conjunctival disease from May 2008 to Aug 2010 in Japan. Topical tacrolimus was instilled 2 times daily for 6 months. The primary endpoint was the change from baseline in papillae-limbus-cornea clinical signs score (based on the presence of papillae, giant papillae, Trantas’ dots, limbal swelling, and corneal epithelial signs). Remission rate following topical tacrolimus treatment was investigated using generalized estimating equations.Results: A total of 1821 subjects were included in the analyses. Six months into treatment, 83.0% and 87.7% of subjects with and without atopic dermatitis, respectively, were in remission (based on the papillae-limbus-cornea grading score). Topical tacrolimus treatment was equally effective in improving papillae-limbus-cornea grading scores from baseline in both study groups after 6 months of treatment. Additionally, the odds ratio for remission increased over time. The concomitant use of topical steroids improved papillae-limbus-cornea grading scores, including papillary signs with a statistically significant, but low odds ratio.Conclusion: Tacrolimus ophthalmic suspension is useful for treating chronic allergic conjunctival disease with and without atopic dermatitis. Clinical response to local tacrolimus therapy is dependent upon treatment duration.

Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

Comparison of Once-Daily Bromfenac 0.07% Versus Once-Daily Nepafenac 0.3% in Patients Undergoing Phacoemulsification.

AimRandomized pilot study comparing clinical outcomes with bromfenac ophthalmic solution 0.07% versus nepafenac 0.3% ophthalmic suspension administered as identical dosing regimens in patients undergoing uncomplicated phacoemulsification with intraocular lens implantation.MethodsForty-nine subjects were treated with bromfenac (n = 25) or nepafenac (n = 24) once daily starting 3 days before cataract surgery, continued on the day of surgery, and for 21 days following surgery, in addition to standard of care. Subjects were followed at 1 day and 7, 21, and 42 days postoperatively. Assessments included best-corrected visual acuity [Early Treatment Diabetic Retinopathy Study (ETDRS)], summed ocular inflammation score (SOIS; anterior chamber cells plus flare grading), macular volume and thickness (spectral domain optical coherence tomography), intraocular pressure, and adverse events.ResultsTreatment groups were similar at baseline. Outcomes for mean letters read (p = 0.20), mean change in macular volume (p = 0.98), and retinal thickness (p = 0.93) were not statistically different between the groups at day 42. Mean SOIS dropped markedly and similarly from post-surgical day 1 to day 7 in both treatment groups and was statistically equivalent to baseline in both groups by day 21. At day 42, 87% of subjects in the bromfenac group and 82% of subjects in the nepafenac group demonstrated stable or improved visual acuity. The proportions of eyes with mean retinal thickness of 10 µm or less at days 7, 21, and 42 were similar for the bromfenac (95.8%, 78.3%, 73.9%, respectively) and nepafenac (91.7%, 87.5%, 66.7%) groups (all p = NS, bromfenac vs. nepafenac).ConclusionBoth bromfenac 0.07% and nepafenac 0.3% produced positive and similar clinical outcomes with regard to ETDRS visual acuity post-cataract surgery when dosed using identical regimens. Increases in mean retinal thickness and mean macular volume were small and similar between treatments.Trial Registration numberNCT01847638.FundingBausch & Lomb Incorporated.

A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis.

PurposeTo evaluate the clinical safety and efficacy of povidone-iodine (PVP-I) 0.6%/dexamethasone (DEX) 0.1% ophthalmic suspension vs vehicle in patients with clinically suspected acute viral conjunctivitis.Patients and methodsThis was a randomized, double-masked, parallel-group, vehicle-controlled study. Adults with a clinical diagnosis of suspected acute viral conjunctivitis were randomized 1:1 to PVP-I/DEX ophthalmic suspension or vehicle bilaterally four times daily for 5 days (Days 1–5). Evaluation was on Days 1, 3 (+1-day window), and 6 (+1). Patients with signs of acute viral conjunctivitis at the Day 6 visit received open-label PVP-I/DEX for five additional days and were evaluated on Day 11–14. The primary efficacy endpoint was clinical resolution of acute viral conjunctivitis in the study eye at the Day 6 visit.ResultsOverall, 132 patients were randomized and received treatment (PVP-I/DEX, n=66; vehicle, n=66); 38 patients continued into the open-label portion of the study. Not enough patients with confirmed adenoviral conjunctivitis (n=32/132) were enrolled to assess the primary endpoint, although there were some efficacy trends in the PVP-I/DEX group for global clinical score (sum of watery conjunctival discharge and bulbar conjunctival redness). There were no serious treatment-emergent adverse events (TEAEs) and no patients discontinued due to a TEAE. In the masked phase, 56.1% of patients receiving PVP-I/DEX experienced at least one TEAE vs 43.9% in the vehicle group; 78.9% of patients in the open-label phase experienced at least one TEAE. Most TEAEs were mild in severity.ConclusionPVP-I/DEX ophthalmic suspension administered for ≤14 days had a favorable safety profile and was generally well tolerated.

Correction to: In Vivo Pharmacokinetics of Bromfenac Ophthalmic Solution 0.075%, Bromfenac Ophthalmic Solution 0.07%, and Nepafenac/Amfenac Ophthalmic Suspension 0.3% in Rabbits.

In the original publication, units were incorrectly published in the results section as micrograms (µg/mL).