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Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT01193127
First received: August 23, 2010
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Cataract
 Drug: OMS302 Solution
Drug: OMS302 Mydriatic Solution
Drug: OMS302 Anti-inflammatory Solution
Drug: Balanced Salt Solution (BSS) Solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:
  • Effect on Post-Operative Pain [ Time Frame: through 12 hours post-surgery ] [ Designated as safety issue: No ]
  • Change in pupil diameter [ Time Frame: during surgery (immediately prior to surgical incision to wound closure) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: duration of study (through Day 30) ] [ Designated as safety issue: Yes ]

Enrollment: 223
Study Start Date: July 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMS302 Solution
OMS302 Solution
 Drug: OMS302 Solution
Experimental: OMS302 Mydriatic Solution
OMS302 Mydriatic Solution
 Drug: OMS302 Mydriatic Solution
Experimental: OMS302 Anti-inflammatory Solution
OMS302 Anti-inflammatory Solution
 Drug: OMS302 Anti-inflammatory Solution
Placebo Comparator: Balanced Salt Solution (BSS) Solution
Balanced Salt Solution (BSS) Solution
 Drug: Balanced Salt Solution (BSS) Solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193127

  Show 24 Study Locations
Sponsors and Collaborators
Omeros Corporation
  More Information

No publications provided

Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT01193127     History of Changes
Other Study ID Numbers: C09-001
Study First Received: August 23, 2010
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Anti-Inflammatory Agents
Mydriatics
 Therapeutic Uses
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013