Clinical trial NCT01454063: Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Official title: A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study of the Effect of OMS302 on Intraoperative Pupil Diameter and Early Postoperative Pain in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intraocular Lens Replacement
Keywords: cataract
lens replacement
Lead sponsor: Omeros Corporation
Sponsor class: INDUSTRY
First posted: 2011-10-18
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Mean Area-under-the-Curve (AUC) Analysis of Change From Baseline in Pupil Diameter (mm) During Surgery
timeFrame: from surgery baseline (pre-incision) through surgery end (time of cortical clean-up/wound closure)
Secondary outcomes:
measure: Mean Area-under-the-Curve Analysis of Ocular Pain Visual Analog Scale (VAS) Score Within 12 Hours Postoperatively
timeFrame: 12 hours
measure: Photophobia at 6 Hours After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)
timeFrame: Six hours postoperatively
measure: Photophobia at Day 1 After Surgery (Ocular Pain and Symptoms Numerical Ordinal Scale [Numerical Rating System - NRS] Scores)
timeFrame: One day
measure: Best Corrected Visual Acuity (BVCA) Log Score on Day 1
timeFrame: One day
measure: Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade on Day 1
timeFrame: One day
measure: Ocular Pain VAS Score After Day of Surgery - Day 1
timeFrame: One day
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Cape Coral
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Stuart
country: United States
state: Florida
city: Bloomington
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Washington
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Goodlettsville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Omeros Corporation
name: Steve Whitaker, MD
role: STUDY_DIRECTOR
References: