Clinical trial NCT01579565: Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
Official title: 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
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: 2012-04-18
Enrollment: 416
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, 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

Primary outcomes:
measure: Mean Area Under the Curve 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)
measure: Mean Area Under the Curve Analysis of Ocular Pain VAS Score Within 12 Hours Postoperatively
timeFrame: 12 hours postoperatively
Secondary outcomes:
measure: Pupil Diameter Greater Than or Equal to 6 mm at Completion of Cortical Clean up
timeFrame: at time of cortical clean-up (i.e., end of surgical procedure)
measure: Pupil Diameter Less Than 6 mm Anytime During Surgery
timeFrame: Intraoperative
measure: Moderate-to-Severe Pain (VAS Greater Than or Equal to 40) at Any Time Point During 12 Hours Postoperatively
timeFrame: 12 hours postoperatively
measure: Ocular Pain-Free (VAS Equal to 0) at All Time Points During 12 Hours Postoperatively
timeFrame: 12 hours postoperatively
measure: Ocular Pain VAS Score on Day 1
timeFrame: One day postoperatively
measure: Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 6 Hours Post-Surgery
timeFrame: Six hours postoperatively
measure: Ocular Symptoms Using Numerical Rating System (NRS) - Photophobia 1 Day Post-Surgery
timeFrame: One day postoperatively
measure: Postoperative Ocular Inflammation - Mean Summed Ocular Inflammation Score (SOIS) on Day 1
timeFrame: One day postoperatively
measure: Postoperative Best Corrected Visual Acuity (BVCA) on Day 1
timeFrame: One day postoperatively
measure: Systemic Pharmacokinetics (PK) of OMS302
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Fort Myers
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
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
city: Zwolle
country: Netherlands
Study officials:
affiliation: Omeros Corporation
name: Steve Whitaker, MD
role: STUDY_DIRECTOR
References: