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NCT04036292 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
A Phase 3 study of Dry Eye Disease (DED), sponsored by Oyster Point Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 758
- Enrollment target
- 20
- Study locations
NCT04036292: Completed Phase 3 study of Dry Eye Disease (DED), sponsored by Oyster Point Pharma.
NCT04036292 is a Phase 3 study of Dry Eye Disease (DED) that has completed, run by Oyster Point Pharma. The registered enrollment target is 758 participants, above the 239-participant average among 3 other Dry Eye Disease (DED) trials with a reported enrollment target (217% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04036292, a Phase 3 study of Dry Eye Disease (DED), has completed, sponsored by Oyster Point Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 758 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
Primary Outcome
The primary endpoint was the percentage of subjects who achieve ≥10 mm improvement in Schirmer's Test Score from baseline to 28 days in the study eye following treatment with OC-01. Schirmer's test scores from 0-35 mm where a higher score is indicative of a better outcome.
Conditions Studied
Interventions
- DRUG Placebo (vehicle) nasal spray
- DRUG OC-01 (varenicline) nasal spray
Study Locations (20)
Texas
- Austin - Austin
- Houston - Houston
- San Antonio - San Antonio
- San Antonio - San Antonio
North Carolina
- Raleigh - Raleigh
- Shelby - Shelby
Arizona
- Phoenix - Phoenix
California
- New Port Beach - Newport Beach
Colorado
- Fort Collins - Fort Collins
Connecticut
- Waterbury - Waterbury
Florida
- Delray Beach - Delray Beach
Indiana
- Indianapolis - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 758 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2021-02-05 |
| Phase | Phase 3 |
What the finished NCT04036292 record still lists
NCT04036292 is an interventional study that assigns participants to a tested intervention. The registered 758 participants enrollment target is mid-sized for trials with a published cap, above the 239-participant average among 3 other Dry Eye Disease (DED) trials with a reported enrollment target (217% higher).
The record links to 1 condition, with Dry Eye Disease (DED) appearing as the primary indexed condition, and to 2 interventions - of which Placebo (vehicle) nasal spray is the first listed.
NCT04036292 names 20 study sites across 16 states, led by Texas, North Carolina, Arizona.
Frequently Asked Questions
What is clinical trial NCT04036292 about?
NCT04036292 is a clinical study titled "Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease". The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
What is the current status of trial NCT04036292?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 758 participants. The study started on 2019-07-23. Estimated completion is 2021-02-05.
What conditions does trial NCT04036292 study?
This clinical trial studies the following conditions: Dry Eye Disease (DED).
What interventions are being tested in trial NCT04036292?
The interventions under investigation include: Placebo (vehicle) nasal spray (DRUG), OC-01 (varenicline) nasal spray (DRUG).
Who is sponsoring clinical trial NCT04036292?
This trial is sponsored by Oyster Point Pharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04036292 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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