Clinical trial NCT01193127: Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract
Lead sponsor: Omeros Corporation
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).


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 with lens replacement surgery in one eye, under topical anesthesia
* Other inclusion criteria to be evaluated by the investigator

Exclusion Criteria:

* 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
* Other exclusion criteria to be evaluated by the investigator

Primary outcomes:
measure: Pupil Diameter (mm) During Surgery
timeFrame: During surgery (immediately prior to surgical incision to wound closure)
measure: Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively
timeFrame: through 12 hours post-surgery
Secondary outcomes:
measure: Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery
timeFrame: Two hours
measure: Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery
timeFrame: Six hours
measure: Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery
timeFrame: One day
measure: Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery
timeFrame: Two days
measure: Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery
timeFrame: Seven days
measure: Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery
timeFrame: 14 days
measure: Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination
timeFrame: up to 30 days
measure: Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery
timeFrame: Two hours
measure: Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery
timeFrame: Six hours
measure: Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery
timeFrame: One day
measure: Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery
timeFrame: Two days
measure: Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery
timeFrame: Seven days
measure: Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery
timeFrame: 14 days
measure: Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination
timeFrame: Up to 30 days
measure: Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery
timeFrame: Two hours
measure: Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery
timeFrame: Six hours
measure: Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery
timeFrame: One day
measure: Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery
timeFrame: Two days
measure: Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery
timeFrame: Seven days
measure: Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery
timeFrame: 14 days
measure: Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination
timeFrame: Up to 30 days
measure: Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery
timeFrame: Two hours
measure: Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery
timeFrame: Six hours
measure: Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery
timeFrame: One day
measure: Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery
timeFrame: Two days
measure: Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery
timeFrame: Seven days
measure: Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery
timeFrame: 14 days
measure: Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination
timeFrame: Up to 30 days
measure: Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery
timeFrame: Two hours
measure: Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery
timeFrame: Six hours
measure: Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery
timeFrame: One day
measure: Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery
timeFrame: Two days
measure: Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days
timeFrame: Seven days
measure: Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery
timeFrame: 14 days
measure: Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination
timeFrame: Up to 30 days
measure: Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery
timeFrame: Two hours
measure: Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery
timeFrame: Six hours
measure: Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery
timeFrame: One day
measure: Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery
timeFrame: Two days
measure: Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery
timeFrame: Seven days
measure: Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery
timeFrame: 14 days
measure: Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination
timeFrame: Up to 30 days
measure: Best Corrected Visual Acuity (BVCA) - Log Score, Baseline
timeFrame: Baseline
measure: Best Corrected Visual Acuity (BVCA) - Log Score, Day 1
timeFrame: One day
measure: Best Corrected Visual Acuity (BVCA) - Log Score, Day 2
timeFrame: Two days
measure: Best Corrected Visual Acuity (BVCA) - Log Score, Day 7
timeFrame: Seven days
measure: Best Corrected Visual Acuity (BVCA) - Log Score, Day 14
timeFrame: 14 days
measure: Best Corrected Visual Acuity (BVCA) - Log Score, Day 30
timeFrame: 30 days
measure: Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline
timeFrame: Baseline
measure: Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery
timeFrame: Two hours
measure: Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1
timeFrame: One day
measure: Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2
timeFrame: Two days
measure: Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7
timeFrame: Seven days
measure: Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14
timeFrame: 14 days
measure: Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30
timeFrame: 30 days
measure: Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline
timeFrame: Baseline
measure: Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery
timeFrame: Two hours
measure: Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1
timeFrame: One day
measure: Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2
timeFrame: Two days
measure: Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7
timeFrame: Seven days
measure: Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14
timeFrame: 14 days
measure: Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30
timeFrame: 30 days
measure: Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery
timeFrame: Two hours
measure: Postoperative Mean Anterior Chamber Cell Count, Day 1
timeFrame: One day
measure: Postoperative Mean Anterior Chamber Cell Count, Day 2
timeFrame: Two days
measure: Postoperative Mean Anterior Chamber Cell Count, Day 7
timeFrame: Seven days
measure: Postoperative Mean Anterior Chamber Cell Count, Day 14
timeFrame: 14 days
measure: Postoperative Mean Anterior Chamber Cell Count, Day 30
timeFrame: 30 days
measure: Ocular Pain VAS Score After Day 0
timeFrame: 43 days
measure: Postoperative Use of Ophthalmic Anti-inflammatory Medications
timeFrame: up to 30 days
measure: Use of Pain Medications at Day 1
timeFrame: One day
measure: Use of Pain Medications After Day 1
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Parker
country: United States
state: Colorado
city: Largo
country: United States
state: Florida
city: North Ft. Myers
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Gurnee
country: United States
state: Illinois
city: Gretna
country: United States
state: Louisiana
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Rockville Centre
country: United States
state: New York
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: Goodlettsville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Nacogdoches
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
Study officials:
References: