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

• Published in: Clinical ophthalmology (Auckland, N.Z.) N.Z.), 2015-01, Vol.9 (default), p.235-243
• Main Authors: Ousler, 3rd, George, Devries, Douglas K, Karpecki, Paul M, Ciolino, Joseph B
• Format: Article
• Language: English
• Subjects: artificial tears; Assessments; Care and treatment; cationic; Comfort; Cornea; Diagnosis; Discomfort; Dosage and administration; dry eye syndrome; Dry eye syndromes; Drying; Emulsions; Eye care products; Eye diseases; Investigations; lipid emulsion; mean breakup area; Ophthalmic drugs; Ophthalmology; Original Research; Quality of life; Questionnaires; Reduction; Signs and symptoms; Staining; Tearing
• ISSN: 1177-5467; 1177-5483; 1177-5483
• DOI: 10.2147/OPTH.S75297

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