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A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease.
- Source :
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Ophthalmology [Ophthalmology] 2019 Sep; Vol. 126 (9), pp. 1230-1237. Date of Electronic Publication: 2019 Apr 06. - Publication Year :
- 2019
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Abstract
- Purpose: To evaluate the safety and efficacy of OTX-101, a novel aqueous nanomicellar formulation of cyclosporine (0.09%), in the treatment of patients with dry eye disease (DED).<br />Design: A randomized, multicenter, vehicle-controlled, double-masked, phase 3 clinical trial.<br />Participants: Adults (18-90 years of age) with a history and clinical diagnosis of DED, a global symptom score of 40 or more (range, 0-100), and a lissamine green conjunctival staining score of 3 or more and 9 or less (range, 0-12) in at least 1 eye.<br />Methods: Eligible patients entered a run-in period of 14 to 20 days in which all patients administered vehicle twice daily. Patients who remained eligible at the baseline (day 0) visit were randomized in a 1:1 ratio to twice-daily treatment with OTX-101 0.09% or vehicle for 84 days.<br />Main Outcome Measures: Efficacy assessments included signs (unanesthetized Schirmer tear test, corneal and conjunctival staining) and symptoms (global symptom score) of DED. The primary end point was the proportion of eyes with a clinically meaningful improvement (increase of ≥10 mm) in Schirmer test score at day 84. Safety evaluations included adverse events (AEs), visual acuity, and intraocular pressure monitoring, slit-lamp, dilated ophthalmoscopy, and fundus examinations.<br />Results: A total of 744 patients were randomized and received study medication (371 to OTX-101 0.09% and 373 to vehicle). The primary end point was achieved; a significantly greater percentage of eyes in the OTX-101 0.09% treatment group achieved an increase of 10 mm or more in the Schirmer test score at day 84 (OTX-101 0.09%, 16.6%; vehicle, 9.2%; P < 0.001). Significant improvements relative to vehicle also were observed for corneal (days 28, 56, and 84) and conjunctival (days 56 and 84) staining. The global symptom score was reduced from baseline in both treatment groups by approximately 30%; however, no significant separation between groups was observed. The OTX-101 0.09% formulation was well tolerated. Treatment-emergent AEs were primarily mild in intensity.<br />Conclusions: Clinically and statistically significant improvements in tear production and ocular surface integrity were observed in patients treated with OTX-101 0.09% for DED.<br /> (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Administration, Ophthalmic
Adolescent
Adult
Aged
Aged, 80 and over
Cyclosporine adverse effects
Double-Blind Method
Dry Eye Syndromes physiopathology
Female
Humans
Immunosuppressive Agents adverse effects
Intraocular Pressure drug effects
Intraocular Pressure physiology
Male
Middle Aged
Ophthalmic Solutions therapeutic use
Surveys and Questionnaires
Tears physiology
Treatment Outcome
Visual Acuity drug effects
Visual Acuity physiology
Young Adult
Cyclosporine therapeutic use
Dry Eye Syndromes drug therapy
Immunosuppressive Agents therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1549-4713
- Volume :
- 126
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Ophthalmology
- Publication Type :
- Academic Journal
- Accession number :
- 30965064
- Full Text :
- https://doi.org/10.1016/j.ophtha.2019.03.050