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NCT04050865 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
A Phase 3 study, sponsored by Ocular Therapeutix.
- Completed
- Registry status
- Phase 3
- Development phase
- 96
- Enrollment target
NCT04050865: Completed Phase 3 study, sponsored by Ocular Therapeutix.
NCT04050865 is a Phase 3 study that has completed, run by Ocular Therapeutix. The registered enrollment target is 96 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04050865, a Phase 3 study, has completed, sponsored by Ocular Therapeutix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 96 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.
Primary Outcome
Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit Increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch i
Interventions
- DRUG Dexamethasone, 0.4mg
- DEVICE Placebo plug with no drug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2019-08-05 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 3 |
What the finished NCT04050865 record still lists
NCT04050865 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone, 0.4mg is the first listed.
NCT04050865 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04050865 about?
NCT04050865 is a clinical study titled "A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis". The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.
What is the current status of trial NCT04050865?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 96 participants. The study started on 2019-08-05. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT04050865?
The interventions under investigation include: Dexamethasone, 0.4mg (DRUG), Placebo plug with no drug (DEVICE).
Who is sponsoring clinical trial NCT04050865?
This trial is sponsored by Ocular Therapeutix, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04050865's enrollment target sits among peer trials
96 1718th of 2000 higher than 282 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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