An evaluation of Retaine™ ophthalmic emulsion in the management of tear film stability and ocular surface staining in patients diagnosed with dry eye

George Ousler III,1 Douglas K Devries,2 Paul M Karpecki,3 Joseph B Ciolino41Ora, Inc, Andover, MA, USA; 2Eye Care Associates of Nevada, Sparks, NV, USA; 3Koffler Vision Group, Lexington, KY, USA; 4Massachusetts Eye and Ear, Boston, MA, USAAbstract: A single-center, open-label study consisting of two visits over the course of approximately 2 weeks was conducted to evaluate the efficacy of Retaine™ ophthalmic emulsion in improving the signs and symptoms of dry eye. Forty-two subjects were enrolled and received 1–2 drops twice daily of Retaine™ beginning at the first visit (day 1) and ending at the second visit. Subjects were instructed to complete a symptomatology diary twice daily prior to drop instillation through the morning of the second visit. Ocular sign and symptom assessments, visual acuity procedures, and comfort assessments were conducted during both visits. A statistically significant reduction was observed in mean breakup area on the second visit between the predose time and the postdose time (P=0.026). On the second visit, subjects had significantly less corneal fluorescein staining in the superior (P=0.002), central (P=0.017), corneal sum (P=0.011), and all ocular regions combined (P=0.038) than on the first visit. On the second visit, statistically significant reductions in dryness (P<0.001), grittiness (P=0.0217), ocular discomfort (P=0.0017), and all symptoms (P<0.001) were also seen as measured by the Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire (0–5 scale). Subjects reported a statistically significant improvement in their abilities to work with a computer at night (P=0.044). Mean drop comfort scores ranged from 1.29–1.81 on the Ora Calibra™ 0–10 Drop Comfort Scale, on which 0 is very comfortable and 10 is very uncomfortable. Retaine™ demonstrates promising results as a novel artificial tear option for individuals suffering from dry eye. The unique mechanism of action of Retaine™ provides enhanced comfort and improves the quality of life of dry eye subjects while reducing the ocular signs of dry eye.Keywords: artificial tears, dry eye syndrome, quality of life, cationic, lipid emulsion, mean breakup are

Reliable intraocular pressure measurement using automated radio-wave telemetry

Eleftherios I Paschalis,* Fabiano Cade,* Samir Melki, Louis R Pasquale, Claes H Dohlman, Joseph B CiolinoMassachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA, USA*These authors contributed equally to this workPurpose: To present an autonomous intraocular pressure (IOP) measurement technique using a wireless implantable transducer (WIT) and a motion sensor.Methods: The WIT optical aid was implanted within the ciliary sulcus of a normotensive rabbit eye after extracapsular clear lens extraction. An autonomous wireless data system (AWDS) comprising of a WIT and an external antenna aided by a motion sensor provided continuous IOP readings. The sensitivity of the technique was determined by the ability to detect IOP changes resulting from the administration of latanoprost 0.005% or dorzolamide 2%, while the reliability was determined by the agreement between baseline and vehicle (saline) IOP.Results: On average, 12 diurnal and 205 nocturnal IOP measurements were performed with latanoprost, and 26 diurnal and 205 nocturnal measurements with dorzolamide. No difference was found between mean baseline IOP (13.08±2.2 mmHg) and mean vehicle IOP (13.27±2.1 mmHg) (P=0.45), suggesting good measurement reliability. Both antiglaucoma medications caused significant IOP reduction compared to baseline; latanoprost reduced mean IOP by 10% (1.3±3.54 mmHg; P<0.001), and dorzolamide by 5% (0.62±2.22 mmHg; P<0.001). Use of latanoprost resulted in an overall twofold higher IOP reduction compared to dorzolamide (P<0.001). Repeatability was ±1.8 mmHg, assessed by the variability of consecutive IOP measurements performed in a short period of time (≤1 minute), during which the IOP is not expected to change.Conclusion: IOP measurements in conscious rabbits obtained without the need for human interactions using the AWDS are feasible and provide reproducible results.Keywords: IOP, pressure transducer, wireless, MEMS, implant, intraocula

Effect of alcaftadine 0.25% on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials

Joseph B Ciolino,1 Eugene B McLaurin,2 Nicholas P Marsico,3 Stacey L Ackerman,4 Julia M Williams,5 Linda Villanueva,5 David A Hollander5 1Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, MA, USA; 2Total Eye Care, P.A., Memphis, TN, USA; 3East West Eye Institute, Los Angeles, CA, USA; 4Philadelphia Eye Associates, Philadelphia, PA, USA; 5Allergan, Inc., Irvine, CA, USA Purpose: Seasonal and perennial allergic conjunctivitis represent the majority of cases of ocular allergy. This analysis was designed to evaluate the efficacy and safety of once-daily alcaftadine 0.25% in preventing ocular itching associated with seasonal or perennial allergic conjunctivitis.Subjects and methods: Pooled data from two double-masked, multicenter, placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis were analyzed. Subjects randomized to receive treatment with alcaftadine 0.25% or placebo were challenged with seasonal (grass, ragweed, trees) or perennial (cat dander, cat hair, dog dander, dust mites, cockroach) allergens, 16 hours after treatment instillation. The primary efficacy measure was subject-evaluated mean ocular itching at 3 minutes post-CAC. Secondary measures included ocular itching at 5 and 7 minutes post-CAC. The proportion of subjects with minimal itch (itch score <1) and zero itch (itch score =0), and safety were also assessed.Results: A total of 189 subjects enrolled in the two studies were treated with alcaftadine or placebo. Overall, 129 subjects were challenged with seasonal allergens and 60 subjects were challenged with perennial allergens. Alcaftadine 0.25% achieved a statistically significant reduction in mean itch score at 3, 5, and 7 minutes post-CAC compared with placebo in subjects challenged with seasonal allergens (P<0.0001 at all time points) and those challenged with perennial allergens (P<0.0001 at all time points). A higher percentage of subjects treated with alcaftadine compared with placebo achieved minimal itch (P≤0.001 versus placebo at all time points) and zero itch (P<0.05 at all time points except 7 minutes for perennial) when challenged with either seasonal or perennial allergens. No treatment-related or serious adverse events were reported.Conclusion: Once-daily alcaftadine 0.25% ophthalmic solution was well tolerated and demonstrated effective relief of ocular itching in subjects challenged with allergens classic for triggering either seasonal or perennial allergic conjunctivitis. Keywords: lastacaft, seasonal allergen, perennial allergen, allergic rhinoconjunctivitis, conjunctival allergen challeng

Evaluation of a new artificial tear formulation for the management of tear film stability and visual function in patients with dry eye

Gail Torkildsen,1 Mile Brujic,2 Michael S Cooper,3 Paul Karpecki,4 Parag Majmudar,5 William Trattler,6 Meryl Reis,7 Joseph B Ciolino1,8 1Andover Eye Clinic, Andover MA, 2Premier Vision Group, Bowling Green, OH, 3Windam Eye Group, Willimantic, CT, 4Gaddie Eye Center, Louisville KY, 5Chicago Cornea Consultants, Chicago IL, 6Center For Excellence in Eye Care, Miami, FL, 7Rohto Mentholatum Research Laboratories, Horsham, PA, 8Massachusetts Eye and Ear Infirmary, Boston MA, USA Purpose: Artificial tears are the first line of therapy for dry eye disease (DED) and are also the most frequently used treatment approach for this common condition. Despite this, there are few published studies that directly compare the effectiveness of different drop preparations, especially those formulated specifically for dry eye. In this study, we tested a new artificial tear product, Rohto® Dry-Aid™, for its ability to relieve the signs and symptoms of DED. The study used a second drop, Systane® Ultra, as a positive comparator.Materials and methods: This was a prospective, single-center, open-label, parallel-group study comparing the effects of the two products when used continuously over ~30 days (Clinical Trials registration number NCT03183089). Subjects were randomly assigned to one of the two test groups and were monitored 2 and 4 weeks after enrollment. Efficacy endpoints included ocular staining, visual function, and ocular discomfort.Results: Treatment groups had similar ocular staining and ocular comfort scores, and both showed statistically significant ocular discomfort score improvement. Subjects in the Rohto group reported significant improvements in visual tasking activities such as watching television and driving at night. There was also a tendency for diary symptom scores to worsen from morning to evening in the Systane group, but not in the Rohto group; this trend was not significant, but warrants further study.Conclusion: The two products, Rohto Dry-Aid and Systane Ultra, elicited comparable effects on the signs and symptoms of DED. While both products are designed to provide long-lasting relief, subjects in the Rohto group experienced a superior relief from discomfort associated with visual tasking activities and daily diaries, indicating that the Rohto drops may provide a longer duration of symptomatic relief over the course of the day. Keywords: artificial tears, dry eye, ocular surface, visual tasking, blurred visio

The TFOS International Workshop on Contact Lens Discomfort: Executive Summary

Contact lens discomfort (CLD) is a frequently experienced problem, with most estimates suggesting that up to half of contact lens wearers experience this problem with some frequency or magnitude. This condition impacts millions of contact lens wearers worldwide. Yet, there is a paucity of consensus and standardization in the scientific and clinical communities on the characterization of the condition, including the definition, classification, epidemiology, pathophysiology, diagnosis, management, influence of contact lens materials, designs and care, and the proper design of clinical trials. \ud \ud The Tear Film & Ocular Surface Society (TFOS), which is a nonprofit organization, has conducted two prior international, consensus building workshops, including the Dry Eye WorkShop (DEWS; available in the public domain at http://www.tearfilm.org/tearfilm-reports-dews-report.php) and the Meibomian Gland Dysfunction Workshop (MGD; available in the public domain at http://www.tearfilm.org/tearfilm-reports-mgdreport.php). To that end, TFOS initiated the process of conducting a similar workshop in January 2012—a process that took approximately 18 months to complete and included 79 experts in the field. These experts participated in one or more topical subcommittees, and were assigned with taking an evidence-based approach at evaluating CLD. Eight topical subcommittees were formed, with each generating a related report, all of which were circulated for presentation, review, and input of the entire workshop membership. \ud \ud The entire workshop originally is being published in this issue of IOVS, in English, with subsequent translations into numerous other languages. All of this information is intended to be available and accessible online, free of charge. This article is intended to serve as an Executive Summary of the eight subcommittee reports, and all information contained here was abstracted from the full reports