Trials / Completed
CompletedNCT02845674
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
An Open-Label Extension of 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
- 258 (actual)
- Sponsor
- Sun Pharmaceutical Industries Limited · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTX-101 0.09% | 0.09% cyclosporine nanomicellar solution |
Timeline
- Start date
- 2016-07-29
- Primary completion
- 2017-08-15
- Completion
- 2017-08-15
- First posted
- 2016-07-27
- Last updated
- 2021-11-19
- Results posted
- 2018-12-14
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02845674. Inclusion in this directory is not an endorsement.