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NCT02132312 · ClinicalTrials.gov registry record · Phase 3
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
A Phase 3 study, sponsored by Omeros Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 78
- Enrollment target
NCT02132312: Completed Phase 3 study, sponsored by Omeros Corporation.
NCT02132312 is a Phase 3 study that has completed, run by Omeros Corporation. The registered enrollment target is 78 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02132312, a Phase 3 study, has completed, sponsored by Omeros Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 78 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.
Primary Outcome
Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm/min) During Surgery Excluding Subjects with In-evaluable Videos.
Interventions
- DRUG OMS302
- DRUG Phenylephrine HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2014-07 |
| Est. Completion | 2016-09-12 |
| Phase | Phase 3 |
What the finished NCT02132312 record still lists
NCT02132312 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which OMS302 is the first listed.
NCT02132312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02132312 about?
NCT02132312 is a clinical study titled "A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement". The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.
What is the current status of trial NCT02132312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 78 participants. The study started on 2014-07. Estimated completion is 2016-09-12.
What interventions are being tested in trial NCT02132312?
The interventions under investigation include: OMS302 (DRUG), Phenylephrine HCl (DRUG).
Who is sponsoring clinical trial NCT02132312?
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 NCT02132312's enrollment target sits among peer trials
78 1769th of 2000 higher than 230 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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