Phase 3
N=416
Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Intraocular Lens Replacement
Bottom Line
View on ClinicalTrials.gov: NCT01579565 ↗Enrolled (actual)
416
Serious AEs
1.0%
Results posted
Aug 2014
Primary outcome: Primary: Mean Area Under the Curve 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
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery |
0.1; -0.5 | 0.0001 sig |
| PRIMARY Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively |
4.3; 8.9 | 0.0002 sig |
| SECONDARY Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up |
187; 154 | 0.0001 sig |
| SECONDARY Pupil Diameter Less Than 6 mm Anytime During Surgery |
18; 76 | 0.0001 sig |
| SECONDARY Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively |
16; 27 | 0.0760 |
| SECONDARY Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively |
56; 41 | 0.0806 |
| SECONDARY Ocular Pain VAS Score on Day 1 |
5.8; 12.2 | 0.0002 sig |
| SECONDARY Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 6 Hours Post-Surgery |
140; 128; 51; 58; 8; 13 | 0.3923 |
| SECONDARY Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 1 Day Post-Surgery |
119; 95; 63; 63; 16; 37 | 0.0060 sig |
| SECONDARY Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1 |
2.8; 2.9 | 0.3286 |
| SECONDARY Postoperative Best Corrected Visual Acuity (BVCA) on Day 1 |
0.1; 0.1 | 0.2361 |
| SECONDARY Systemic Pharmacokinetics (PK) of OMS302 |
1; 0; 10; 1 | — |
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.
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 (NCT01579565). 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.