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NCT03452397 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)
A Phase 2 study of Dry Eye Disease, sponsored by Oyster Point Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
- 3
- Study locations
NCT03452397: Completed Phase 2 study of Dry Eye Disease, sponsored by Oyster Point Pharma.
NCT03452397 is a Phase 2 study of Dry Eye Disease that has completed, run by Oyster Point Pharma. The registered enrollment target is 165 participants, below the 250-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (34% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03452397, a Phase 2 study of Dry Eye Disease, has completed, sponsored by Oyster Point Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
- 3
- Study locations
Study Summary
The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
Primary Outcome
The primary endpoint was the change in anesthetized Schirmer's Test Score (STS) from baseline to Day 1. Change in Schirmer test score pre to post treatment. The Schirmer's test measures the amount of tears produced by placing a paper strip in the eye for 5 minutes and distance of wetting was recorded. 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 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL)
- DRUG 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL)
- DRUG 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL)
Study Locations (3)
Kentucky
- Louisville - Louisville
Massachusetts
- Andover - Andover
Tennessee
- Nashville - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2018-02-27 |
| Est. Completion | 2018-04-27 |
| Phase | Phase 2 |
What the finished NCT03452397 record still lists
NCT03452397 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 250-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 4 interventions - of which Placebo (vehicle) nasal spray is the first listed.
NCT03452397 reports a single indexed study location in Kentucky, Massachusetts, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03452397 about?
NCT03452397 is a clinical study titled "Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)". The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.
What is the current status of trial NCT03452397?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2018-02-27. Estimated completion is 2018-04-27.
What conditions does trial NCT03452397 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT03452397?
The interventions under investigation include: Placebo (vehicle) nasal spray (DRUG), 0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) (DRUG), 1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) (DRUG), 2.0 % hemigalactarate (0.11% free base) 2.0 % OC-02 High Dose (11.1 mg/mL) (DRUG).
Who is sponsoring clinical trial NCT03452397?
This trial is sponsored by Oyster Point Pharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03452397 being conducted?
This trial has 3 study locations across Kentucky, Massachusetts, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03452397's enrollment target sits among peer trials
165 18th of 33 higher than 16 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease 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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