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NCT02128113 · ClinicalTrials.gov registry record · Phase 2
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 307
- Enrollment target
NCT02128113: Completed Phase 2 study, sponsored by Biogen.
NCT02128113 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 307 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (131% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02128113, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 307 participants
- Enrollment target
Study Summary
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
Primary Outcome
Count of central corneal endothelial cells 12 weeks post cataract surgery, compared to baseline
Interventions
- DRUG Vehicle Ophthalmic Solution
- DRUG Omaveloxolone Ophthalmic Suspension 0.5%
- DRUG Omaveloxolone Ophthalmic Suspension 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2014-05-31 |
| Est. Completion | 2015-04-30 |
| Phase | Phase 2 |
What the finished NCT02128113 record still lists
NCT02128113 is an interventional study that assigns participants to a tested intervention. The registered 307 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 (131% higher).
The record links to 0 conditions, and to 3 interventions - of which Vehicle Ophthalmic Solution is the first listed.
NCT02128113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02128113 about?
NCT02128113 is a clinical study titled "RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD". This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
What is the current status of trial NCT02128113?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 307 participants. The study started on 2014-05-31. Estimated completion is 2015-04-30.
What interventions are being tested in trial NCT02128113?
The interventions under investigation include: Vehicle Ophthalmic Solution (DRUG), Omaveloxolone Ophthalmic Suspension 0.5% (DRUG), Omaveloxolone Ophthalmic Suspension 1% (DRUG).
Who is sponsoring clinical trial NCT02128113?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02128113's enrollment target sits among peer trials
307 165th of 2000 higher than 1,836 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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