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NCT02254265 · ClinicalTrials.gov registry record · Phase 2
Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
A Phase 2 study, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 455
- Enrollment target
NCT02254265: Completed Phase 2 study, sponsored by Sun Pharmaceutical Industries Limited.
NCT02254265 is a Phase 2 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 455 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (242% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02254265, a Phase 2 study, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 455 participants
- Enrollment target
Study 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).
Primary Outcome
Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye. The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale
Interventions
- DRUG Vehicle
- DRUG OTX-101 0.05%
- DRUG OTX-101 0.09%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2014-09 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT02254265 record still lists
NCT02254265 is an interventional study that assigns participants to a tested intervention. The registered 455 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (242% higher).
The record links to 0 conditions, and to 3 interventions - of which Vehicle is the first listed.
NCT02254265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02254265 about?
NCT02254265 is a clinical study titled "Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca". 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).
What is the current status of trial NCT02254265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 455 participants. The study started on 2014-09. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02254265?
The interventions under investigation include: Vehicle (DRUG), OTX-101 0.05% (DRUG), OTX-101 0.09% (DRUG).
Who is sponsoring clinical trial NCT02254265?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02254265's enrollment target sits among peer trials
455 85th of 2000 higher than 1,914 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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