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NCT03920215 · ClinicalTrials.gov registry record · Phase 2
Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
A Phase 2 study of Long Term Follow up Dry Eye Disease, sponsored by Oyster Point Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
- 3
- Study locations
NCT03920215: Completed Phase 2 study of Long Term Follow up Dry Eye Disease, sponsored by Oyster Point Pharma.
NCT03920215 is a Phase 2 study of Long Term Follow up Dry Eye Disease that has completed, run by Oyster Point Pharma. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03920215, a Phase 2 study of Long Term Follow up Dry Eye Disease, has completed, sponsored by Oyster Point Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
- 3
- Study locations
Study Summary
The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).
Primary Outcome
Number of Participants with the Left Nostril/Abnormal at 6 months as assessed by Intranasal Examinations
Conditions Studied
Interventions
- DRUG OC-01 Low Dose, 0.12 mg/mL
- DRUG OC-01 Mid Dose, 0.6 mg/mL
- DRUG OC-01 High Dose, 1.2 mg/mL
- DRUG Placebo (vehicle) nasal spray
Study Locations (3)
California
- Newport Beach - Newport Beach
Indiana
- Indianapolis - Indianapolis
Massachusetts
- Andover - Andover
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2018-08-15 |
| Est. Completion | 2019-09-20 |
| Phase | Phase 2 |
What the finished NCT03920215 record still lists
NCT03920215 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Long Term Follow up Dry Eye Disease appearing as the primary indexed condition, and to 4 interventions - of which OC-01 Low Dose, 0.12 mg/mL is the first listed.
NCT03920215 reports a single indexed study location in California, Indiana, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03920215 about?
NCT03920215 is a clinical study titled "Evaluation of the Long Term Follow up of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease". The objective of this safety long-term follow-up study was to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study (NCT03636061).
What is the current status of trial NCT03920215?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2018-08-15. Estimated completion is 2019-09-20.
What conditions does trial NCT03920215 study?
This clinical trial studies the following conditions: Long Term Follow up Dry Eye Disease.
What interventions are being tested in trial NCT03920215?
The interventions under investigation include: OC-01 Low Dose, 0.12 mg/mL (DRUG), OC-01 Mid Dose, 0.6 mg/mL (DRUG), OC-01 High Dose, 1.2 mg/mL (DRUG), Placebo (vehicle) nasal spray (DRUG).
Who is sponsoring clinical trial NCT03920215?
This trial is sponsored by Oyster Point Pharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03920215 being conducted?
This trial has 3 study locations across California, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03920215's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 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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