Trials / Completed
CompletedNCT02688556
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 745 (actual)
- Sponsor
- Sun Pharmaceutical Industries Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cyclosporine | |
| DRUG | vehicle of OTX-101 |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2016-11-01
- Completion
- 2016-12-01
- First posted
- 2016-02-23
- Last updated
- 2022-08-29
- Results posted
- 2019-04-08
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02688556. Inclusion in this directory is not an endorsement.