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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: Completed Phase 1 study of Dry Eye Disease, sponsored by Ocular Therapeutix.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
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 |
What the finished NCT04362670 record still lists
NCT04362670 is an interventional study that assigns participants to a tested intervention. The registered 153 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 (39% lower).
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 lists 15 locations in 9 states (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.
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 NCT04362670's enrollment target sits among peer trials
153 19th of 33 higher than 15 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.
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