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NCT01454063 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
A Phase 3 study, sponsored by Omeros Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 405
- Enrollment target
NCT01454063: Completed Phase 3 study, sponsored by Omeros Corporation.
NCT01454063 is a Phase 3 study that has completed, run by Omeros Corporation. The registered enrollment target is 405 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01454063, a Phase 3 study, has completed, sponsored by Omeros Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 405 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug) for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
Primary Outcome
Change in pupil diameter over time from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment arm and time-point (every minute). The primary analysis of the change in pupil diameter was 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 ru
Interventions
- DRUG Placebo
- DRUG OMS302
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
What the finished NCT01454063 record still lists
NCT01454063 is an interventional study that assigns participants to a tested intervention. The registered 405 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 (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01454063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01454063 about?
NCT01454063 is a clinical study titled "Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification". The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug) for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
What is the current status of trial NCT01454063?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2011-09. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01454063?
The interventions under investigation include: Placebo (DRUG), OMS302 (DRUG).
Who is sponsoring clinical trial NCT01454063?
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 NCT01454063's enrollment target sits among peer trials
405 914th of 2000 higher than 1,087 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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