Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
1 other identifier
interventional
223
1 country
24
Brief Summary
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2010
Shorter than P25 for phase_2
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 23, 2010
CompletedFirst Posted
Study publicly available on registry
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
August 28, 2014
CompletedAugust 28, 2014
August 1, 2014
6 months
August 23, 2010
July 2, 2014
August 27, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Pupil Diameter (mm) During Surgery
Pupil diameter from surgical baseline (immediately prior to surgical incision) to the end of the surgical procedure (wound closure) was summarized using descriptive statistics by treatment group and time point. Repeated measures analyses of variance were used to test for differences in the maintenance of mydriasis. The repeated measures model included change from baseline pupil diameter as the response variable and treatment (OMS302, ketorolac tromethamine, and vehicle), time point (as a categorical variable) and the stratification factor lens opacities classification system II (LOCS II) grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working-correlation structure was used.
During surgery (immediately prior to surgical incision to wound closure)
Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively
For the primary analysis of this endpoint, only the results on the day of operation at 2, 4, 6, 8 and 10-12 hours were utilized. The VAS scores (where 0 = no pain and 100 = worst possible pain) were summarized by treatment group and time point. Repeated measures analyses of variance were used to test for differences in postoperative ocular pain. The repeated measures model included VAS pain score as the response variable and treatment (OMS302, phenylephrine hydrochloride (PE), and vehicle), time point (as a categorical variable) and the stratification factor LOCS II grade as predictor variables. A generalized estimating equation (GEE) approach with an AR(1) working correlation structure was used.
through 12 hours post-surgery
Secondary Outcomes (72)
Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery
Two hours
Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery
Six hours
Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery
One day
Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery
Two days
Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery
Seven days
- +67 more secondary outcomes
Study Arms (4)
OMS302 Solution
EXPERIMENTALOMS302 Solution
OMS302 Mydriatic Solution
EXPERIMENTALOMS302 Mydriatic Solution
OMS302 Anti-inflammatory Solution
EXPERIMENTALOMS302 Anti-inflammatory Solution
Balanced Salt Solution (BSS) Solution
PLACEBO COMPARATORBalanced Salt Solution (BSS) Solution
Interventions
Eligibility Criteria
You may qualify if:
- Competent and willing to voluntarily provide informed consent
- years of age or older
- In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
You may not qualify if:
- No allergies to the medications and/or the active ingredients of any of the study medications
- No medications with the same activities as the 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Glendale, Arizona, 85308, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Los Angeles, California, 90013, United States
Unknown Facility
Parker, Colorado, 80134, United States
Unknown Facility
Largo, Florida, 33770, United States
Unknown Facility
North Fort Myers, Florida, 33903, United States
Unknown Facility
Panama City, Florida, 32405, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Gurnee, Illinois, 60031, United States
Unknown Facility
Gretna, Louisiana, 70056, United States
Unknown Facility
Kansas City, Missouri, 64111, United States
Unknown Facility
St Louis, Missouri, 63131, United States
Unknown Facility
Omaha, Nebraska, 68131, United States
Unknown Facility
Las Vegas, Nevada, 89135, United States
Unknown Facility
Albuquerque, New Mexico, 87113, United States
Unknown Facility
Rockville Centre, New York, 11570, United States
Unknown Facility
Bala-Cynwyd, Pennsylvania, 19004, United States
Unknown Facility
Goodlettsville, Tennessee, 37072, United States
Unknown Facility
Austin, Texas, 78731, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
Nacogdoches, Texas, 75965, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Omeros Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2010
First Posted
September 1, 2010
Study Start
July 1, 2010
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
August 28, 2014
Results First Posted
August 28, 2014
Record last verified: 2014-08