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NCT01579565 · ClinicalTrials.gov registry record · Phase 3
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
A Phase 3 study of Intraocular Lens Replacement, sponsored by Omeros Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 416
- Enrollment target
- 14
- Study locations
NCT01579565: Completed Phase 3 study of Intraocular Lens Replacement, sponsored by Omeros Corporation.
NCT01579565 is a Phase 3 study of Intraocular Lens Replacement that has completed, run by Omeros Corporation. The registered enrollment target is 416 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01579565, a Phase 3 study of Intraocular Lens Replacement, has completed, sponsored by Omeros Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 416 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
Primary Outcome
The co-primary analysis of the change in pupil diameter based on the mean area under the curve (AUC) pupil diameter change from baseline. First, the AUC of the pupil diameter from surgical baseline to wound closure was calculated using the trapezoidal rule. Second, the mean AUC was obtained by dividing the AUC by the total time of surgery. Third, the mean AUC of change from baseline was calculated by subtracting the baseline pupil diameter from the mean AUC.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG OMS302
Study Locations (14)
Texas
- - Austin
- - Houston
- - San Antonio
Missouri
- - St Louis
- - Washington
Arizona
- - Chandler
California
- - Los Angeles
Florida
- - Fort Myers
Massachusetts
- - Boston
New Mexico
- - Albuquerque
New York
- - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-01 |
| Phase | Phase 3 |
What the finished NCT01579565 record still lists
NCT01579565 is an interventional study that assigns participants to a tested intervention. The registered 416 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Intraocular Lens Replacement appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01579565 lists 14 locations in 11 states (Texas, Missouri, Arizona).
Frequently Asked Questions
What is clinical trial NCT01579565 about?
NCT01579565 is a clinical study titled "Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification". The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
What is the current status of trial NCT01579565?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2012-04. Estimated completion is 2013-01.
What conditions does trial NCT01579565 study?
This clinical trial studies the following conditions: Intraocular Lens Replacement.
What interventions are being tested in trial NCT01579565?
The interventions under investigation include: Placebo (DRUG), OMS302 (DRUG).
Who is sponsoring clinical trial NCT01579565?
This trial is sponsored by Omeros Corporation, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01579565 being conducted?
This trial has 14 study locations across Arizona, California, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01579565's enrollment target sits among peer trials
416 902nd of 2000 higher than 1,098 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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