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NCT01193127 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
A Phase 2 study, sponsored by Omeros Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 223
- Enrollment target
NCT01193127: Completed Phase 2 study, sponsored by Omeros Corporation.
NCT01193127 is a Phase 2 study that has completed, run by Omeros Corporation. The registered enrollment target is 223 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01193127, a Phase 2 study, has completed, sponsored by Omeros Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 223 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).
Primary Outcome
Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categor
Interventions
- DRUG OMS302 Solution
- DRUG OMS302 Mydriatic Solution
- DRUG OMS302 Anti-inflammatory Solution
- DRUG Balanced Salt Solution (BSS) Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 223 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-02 |
| Phase | Phase 2 |
What the finished NCT01193127 record still lists
NCT01193127 is an interventional study that assigns participants to a tested intervention. The registered 223 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 (68% higher).
The record links to 0 conditions, and to 4 interventions - of which OMS302 Solution is the first listed.
NCT01193127 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01193127 about?
NCT01193127 is a clinical study titled "Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)". The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (...
What is the current status of trial NCT01193127?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 223 participants. The study started on 2010-07. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01193127?
The interventions under investigation include: OMS302 Solution (DRUG), OMS302 Mydriatic Solution (DRUG), OMS302 Anti-inflammatory Solution (DRUG), Balanced Salt Solution (BSS) Solution (DRUG).
Who is sponsoring clinical trial NCT01193127?
This trial is sponsored by Omeros Corporation, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01193127's enrollment target sits among peer trials
223 274th of 2000 higher than 1,727 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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