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NCT04130802 · ClinicalTrials.gov registry record · Phase 2
OCS-01 in Treating Inflammation and Pain in Post-cataract Patients
A Phase 2 study, sponsored by Oculis.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
NCT04130802: Completed Phase 2 study, sponsored by Oculis.
NCT04130802 is a Phase 2 study that has completed, run by Oculis. The registered enrollment target is 153 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04130802, a Phase 2 study, has completed, sponsored by Oculis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
Study Summary
The DX-216 trial is a randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle in the treatment of inflammation and pain following cataract surgery. The primary objective is to evaluate the efficacy and safety of OCS-01 compared to placebo and the secondary objective is to evaluate the optimal dosing frequency (once a day \[QD\] or twice a day \[BID\]).
Primary Outcome
Absence of anterior chamber cells as measured by slit beam with fluorescein. The anterior chamber cell count was recorded as the actual number of cells observed if ≤10 cells were seen, otherwise a range was reported. The observed anterior chamber cell count at Visit 6 was used and categorized for analysis as follows: * Absence of anterior chamber cells: anterior chamber cell count of 0 / Grade 0 * Presence of anterior chamber cells: anterior chamber cell count of 1 or more / Grade 1, 2, 3, or 4
Interventions
- DRUG Placebo
- DRUG OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2019-09-27 |
| Est. Completion | 2020-01-31 |
| Phase | Phase 2 |
What the finished NCT04130802 record still lists
NCT04130802 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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04130802 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04130802 about?
NCT04130802 is a clinical study titled "OCS-01 in Treating Inflammation and Pain in Post-cataract Patients". The DX-216 trial is a randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle in the treatment of inflammation and pain following cataract surgery. The primary objective is to evaluate the efficacy and safety of OCS-...
What is the current status of trial NCT04130802?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2019-09-27. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT04130802?
The interventions under investigation include: Placebo (DRUG), OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL (DRUG).
Who is sponsoring clinical trial NCT04130802?
This trial is sponsored by Oculis, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04130802's enrollment target sits among peer trials
153 449th of 2000 higher than 1,549 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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