Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification (OMS302-ILR-003)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT01454063
First received: October 13, 2011
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Intraocular Lens Replacement
Drug: OMS302
Drug: Placebo
Phase 3

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

Further study details as provided by Omeros Corporation:

Primary Outcome Measures:
  • Intraoperative pupil diameter [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on intraoperative pupil diameter.


Secondary Outcome Measures:
  • Pain during the early postoperative period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on pain during the early postoperative period.

  • Postoperative best-corrected visual acuity (BCVA) [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    To evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on postoperative best-corrected visual acuity (BCVA).

  • Postoperative inflammation as measured by Summed Ocular Inflammation Score (SOIS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on postoperative inflammation as measured by Summed Ocular Inflammation Score (SOIS).

  • Pain after the early postoperative period [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on pain after the early postoperative period.

  • Safety as measured by adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    To evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on safety as measured by adverse events

  • Postoperative photophobia as measured by the photophobia subscale of the Numerical Rating System (NRS) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    To evaluate the effect of OMS302 compared to placebo when administered in irrigation solution during phacoemulsification and intraocular lens replacement on postoperative photophobia as measured by the photophobia subscale of the Numerical Rating System (NRS).


Enrollment: 405
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMS302
OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Drug: OMS302
OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS solution through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS solution.
Placebo Comparator: Placebo
Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Drug: Placebo
Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS solution through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454063

Locations
United States, Arizona
Chandler, Arizona, United States, 85224
Glendale, Arizona, United States, 85308
United States, California
Los Angeles, California, United States, 90013
United States, Florida
Cape Coral, Florida, United States, 33904
Fort Myers, Florida, United States, 33901
Stuart, Florida, United States, 34994
United States, Minnesota
Bloomington, Minnesota, United States, 55431
United States, Missouri
Saint Louis, Missouri, United States, 63131
Washington, Missouri, United States, 63090
United States, New Mexico
Albuquerque, New Mexico, United States, 87113
United States, New York
New York, New York, United States, 10021
United States, Tennessee
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Austin, Texas, United States, 78731
Houston, Texas, United States, 77024
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Omeros Corporation
Investigators
Study Director: Steve Whitaker, MD Omeros Corporation
  More Information

No publications provided

Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT01454063     History of Changes
Other Study ID Numbers: OMS302 ILR 003
Study First Received: October 13, 2011
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Omeros Corporation:
cataract
lens replacement

ClinicalTrials.gov processed this record on April 23, 2014