Phase 3
N=405
Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Intraocular Lens Replacement
Bottom Line
View on ClinicalTrials.gov: NCT01454063 ↗Enrolled (actual)
405
Serious AEs
0.3%
Results posted
Aug 2014
Primary outcome: Primary: Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery — 0.1; -0.5 mm — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OMS302 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Omeros Corporation
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery |
0.1; -0.5 | <0.0001 sig |
| SECONDARY Mean Area-under-the-Curve Analysis of Ocular Pain Visual Analog Scale (VAS) Score Within 12 Hours Postoperatively |
4.1; 9.2 | <0.0001 sig |
| SECONDARY Photophobia at 6 Hours After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores) |
108; 133; 70; 46; 17; 19 | 0.0514 |
| SECONDARY Photophobia at Day 1 After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores) |
125; 90; 48; 63; 20; 38 | 0.0034 sig |
| SECONDARY Best Corrected Visual Acuity (BVCA) Log Score on Day 1 |
0.1; 0.1 | 0.0963 |
| SECONDARY Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade on Day 1 |
2.7; 2.9 | 0.0532 |
| SECONDARY Ocular Pain VAS Score After Day of Surgery - Day 1 |
5.9; 14.2 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Competent and willing to voluntarily provide informed consent
- 18 years of age or older
- In good general health needing to undergo cataract extraction or lens extraction with lens replacement surgery in one eye, under topical anesthesia
Exclusion Criteria
- No allergies to the medications and/or the active ingredients of any of the study medications
- No medications with the same activities of the active ingredients in OMS302 for defined time intervals prior to and after surgery
- No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
Data sourced from ClinicalTrials.gov (NCT01454063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.