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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03452397
The ClinicalTrials.gov registry entry for NCT03452397 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 250-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (34% lower). The listed sponsor is Oyster Point Pharma, which has 10 total studies on file at ClinicalTrials.gov.
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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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