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NCT03633461 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)
A Phase 2 study, sponsored by Oyster Point Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT03633461: Completed Phase 2 study, sponsored by Oyster Point Pharma.
NCT03633461 is a Phase 2 study that has completed, run by Oyster Point Pharma. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03633461, a Phase 2 study, has completed, sponsored by Oyster Point Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray compared to placebo on signs and symptoms of dry eye disease (DED).
Primary Outcome
The primary end point was the change in anesthetized Schirmer's Test Score (STS) from baseline to 28 days in the study eye following treatment with OC-02. Schirmer's test score from 0-35 mm where a higher score is indicative of a better outcome.
Interventions
- DRUG Placebo (vehicle) nasal spray
- DRUG OC-02 (simpinicline) nasal spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2018-08-14 |
| Est. Completion | 2018-09-20 |
| Phase | Phase 2 |
What the finished NCT03633461 record still lists
NCT03633461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (vehicle) nasal spray is the first listed.
NCT03633461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03633461 about?
NCT03633461 is a clinical study titled "Evaluation of the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)". The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray compared to placebo on signs and symptoms of dry eye disease (DED).
What is the current status of trial NCT03633461?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2018-08-14. Estimated completion is 2018-09-20.
What interventions are being tested in trial NCT03633461?
The interventions under investigation include: Placebo (vehicle) nasal spray (DRUG), OC-02 (simpinicline) nasal spray (DRUG).
Who is sponsoring clinical trial NCT03633461?
This trial is sponsored by Oyster Point Pharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03633461's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 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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