Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
Public ClinicalTrials.gov record NCT04362670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04362670
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 23, 2020 (Actual)
- Primary completion
- Aug 11, 2021 (Actual)
- Completion
- Aug 11, 2021 (Actual)
- Last update posted
- Nov 14, 2023
2020 – 2021
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ocular Therapeutix, Inc. | Garden Grove | California | 92843 | — |
| Ocular Therapeutix, Inc. | Inglewood | California | 90301 | — |
| Ocular Therapeutix, Inc. | Mission Hills | California | 91345 | — |
| Ocular Therapeutix, Inc. | Delray Beach | Florida | 33484 | — |
| Ocular Therapeutix, Inc. | Largo | Florida | 33773 | — |
| Ocular Therapeutix, Inc. | Lake Villa | Illinois | 60046 | — |
| Ocular Therapeutix, Inc. | Kansas City | Missouri | 64111 | — |
| Ocular Therapeutix, Inc | St Louis | Missouri | 63128 | — |
| Ocular Therapeutix | St Louis | Missouri | 63131 | — |
| Ocular Therapeutix, Inc. | Cleveland | Ohio | 44115 | — |
| Ocular Therapeutix, Inc. | Cranberry Township | Pennsylvania | 16066 | — |
| Ocular Therapeutix, Inc. | Memphis | Tennessee | 38119 | — |
| Ocular Therapeutix, Inc. | El Paso | Texas | 79902 | — |
| Ocular Therapeutix | Lakeway | Texas | 78738 | — |
| Ocular Therapeutix, Inc. | Murray | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04362670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 14, 2023 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04362670 live on ClinicalTrials.gov.