A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease
| Autor: | Angela Justice, Ranjan Malhotra, Sidney L Weiss, John D. Sheppard, Barry A Schechter, Damien F Goldberg |
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| Rok vydání: | 2019 |
| Předmět: |
0303 health sciences
Intraocular pressure medicine.medical_specialty Visual acuity medicine.diagnostic_test business.industry Phases of clinical research Fundus (eye) eye diseases law.invention Clinical trial Ophthalmoscopy 03 medical and health sciences Ophthalmology 0302 clinical medicine Randomized controlled trial law 030221 ophthalmology & optometry Clinical endpoint medicine medicine.symptom business 030304 developmental biology |
| Zdroj: | Ophthalmology. 126:1230-1237 |
| ISSN: | 0161-6420 |
| Popis: | 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). Design A randomized, multicenter, vehicle-controlled, double-masked, phase 3 clinical trial. 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. 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. 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. 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 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. |
| Databáze: | OpenAIRE |
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