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NCT03785340 · ClinicalTrials.gov registry record · Phase 3
Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)
A Phase 3 study, sponsored by Ocugen.
- Completed
- Registry status
- Phase 3
- Development phase
- 252
- Enrollment target
NCT03785340: Completed Phase 3 study, sponsored by Ocugen.
NCT03785340 is a Phase 3 study that has completed, run by Ocugen. The registered enrollment target is 252 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03785340, a Phase 3 study, has completed, sponsored by Ocugen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 252 participants
- Enrollment target
Study Summary
This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).
Primary Outcome
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score
Interventions
- DRUG Placebos
- DRUG Brimonidine Tartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2018-12-03 |
| Est. Completion | 2019-02-25 |
| Phase | Phase 3 |
What the finished NCT03785340 record still lists
NCT03785340 is an interventional study that assigns participants to a tested intervention. The registered 252 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03785340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03785340 about?
NCT03785340 is a clinical study titled "Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)". This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).
What is the current status of trial NCT03785340?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 252 participants. The study started on 2018-12-03. Estimated completion is 2019-02-25.
What interventions are being tested in trial NCT03785340?
The interventions under investigation include: Placebos (DRUG), Brimonidine Tartrate (DRUG).
Who is sponsoring clinical trial NCT03785340?
This trial is sponsored by Ocugen, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03785340's enrollment target sits among peer trials
252 1246th of 2000 higher than 752 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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