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NCT04362670 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
A Phase 1 study of Dry Eye Disease, sponsored by Ocular Therapeutix.
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
- 15
- Study locations
NCT04362670 is a Phase 1 study of Dry Eye Disease that has completed, run by Ocular Therapeutix. The registered enrollment target is 153 participants, below the 250-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (39% lower). The trial reports 15 study locations across 9 states.
The verdict
NCT04362670, a Phase 1 study of Dry Eye Disease, has completed, sponsored by Ocular Therapeutix.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
- 15
- Study locations
Study Summary
To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
Conditions Studied
Interventions
- DRUG OTX-CSI
- OTHER Placebo Vehicle
Study Locations (15)
California
- Ocular Therapeutix, Inc. - Garden Grove
- Ocular Therapeutix, Inc. - Inglewood
- Ocular Therapeutix, Inc. - Mission Hills
Missouri
- Ocular Therapeutix, Inc. - Kansas City
- Ocular Therapeutix, Inc - St Louis
- Ocular Therapeutix - St Louis
Florida
- Ocular Therapeutix, Inc. - Delray Beach
- Ocular Therapeutix, Inc. - Largo
Texas
- Ocular Therapeutix, Inc. - El Paso
- Ocular Therapeutix - Lakeway
Illinois
- Ocular Therapeutix, Inc. - Lake Villa
Ohio
- Ocular Therapeutix, Inc. - Cleveland
Pennsylvania
- Ocular Therapeutix, Inc. - Cranberry Township
Tennessee
- Ocular Therapeutix, Inc. - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2020-04-23 |
| Est. Completion | 2021-08-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04362670
The ClinicalTrials.gov registry entry for NCT04362670 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 153 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 (39% lower). The listed sponsor is Ocular Therapeutix, which has 20 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 2 interventions - of which OTX-CSI is the first listed.
NCT04362670 reports 15 study locations spanning 9 distinct geographic areas - top geographies include California, Missouri, Florida.
Frequently Asked Questions
What is clinical trial NCT04362670 about?
NCT04362670 is a clinical study titled "Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.". To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
What is the current status of trial NCT04362670?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2020-04-23. Estimated completion is 2021-08-11.
What conditions does trial NCT04362670 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT04362670?
The interventions under investigation include: OTX-CSI (DRUG), Placebo Vehicle (OTHER).
Who is sponsoring clinical trial NCT04362670?
This trial is sponsored by Ocular Therapeutix, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04362670 being conducted?
This trial has 15 study locations across California, Florida, Illinois, Missouri, Ohio. 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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