A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Pharmacokinetics of OMS302 and the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Omeros Corporation
- Enrollment
- 416
- Primary Endpoint
- Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
OMS302
OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Intervention: OMS302 (Drug)
Placebo
Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively
Time Frame: 12 hours postoperatively
The co-primary analysis of the ocular pain VAS (where 0 = no pain and 100 = worst possible pain) based on the mean area under the curve (AUC). The AUC of the ocular pain VAS during 12 hours postoperatively was calculated by the trapezoidal rule in which the hour 11 was used to represent the time-point 10-12 hour. The mean AUC was defined as the AUC divided by the number of hours with ocular pain VAS results during the first 12 hours postoperatively.
Mean Area Under the Curve Analysis of Change-from-Baseline in Pupil Diameter (mm) During Surgery
Time Frame: From surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)
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.
Secondary Outcomes
- Pupil Diameter Less Than 6 mm Anytime During Surgery(Intraoperative)
- Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively(12 hours postoperatively)
- Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 6 Hours Post-Surgery(Six hours postoperatively)
- Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up(at time of cortical clean-up (i.e., end of surgical procedure))
- Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively(12 hours postoperatively)
- Ocular Pain VAS Score on Day 1(One day postoperatively)
- Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 1 Day Post-Surgery(One day postoperatively)
- Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1(One day postoperatively)
- Postoperative Best Corrected Visual Acuity (BVCA) on Day 1(One day postoperatively)
- Systemic Pharmacokinetics (PK) of OMS302(24 hours)