NCT02254265

Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

A Randomized, Multicenter, Double-Masked, Vehicle-Controlled, Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).

Detailed description

Keratoconjunctivitis sicca (KCS) is a common multifactorial ophthalmologic disorder of the tears and ocular surface characterized by symptoms of burning, stinging, itching, grittiness, scratchiness, foreign body sensation, dryness, stickiness and tired eye sensation. This study is the first clinical safety and efficacy study with OTX-101 and is designed to compare two dose concentrations of OTX-101 against vehicle (placebo) in reducing the signs and symptoms of KCS and evaluate safety when dosed twice a day in both eyes over an 84 day period.

Conditions

• Keratoconjunctivitis Sicca
• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	OTX-101 0.05%	OTX-101 0.05% Ophthalmic Solution
DRUG	OTX-101 0.09%	OTX-101 0.09% Ophthalmic Solution
DRUG	Vehicle	Vehicle of OTX-101 Ophthalmic Solution

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-10-01
• Last updated: 2022-08-29
• Results posted: 2018-12-14

Locations

1 site across 1 country: United States