Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01230125
First received: October 25, 2010
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Condition Intervention Phase
Cataract
Drug: Mapracorat
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study to Assess the Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Resolution of anterior chamber (AC) cells [ Time Frame: postoperative day 8 ] [ Designated as safety issue: No ]
    number of anterior chamber (AC) cells in study eyes measured on a scale of 0-4.

  • Pain Scale [ Time Frame: postoperative day 8 ] [ Designated as safety issue: No ]
    eye pain measured on a visual analog scale.


Secondary Outcome Measures:
  • Resolution of AC cells [ Time Frame: Over all study visits - through postoperative day 15 +/- 1 day ] [ Designated as safety issue: No ]
    number of anterior chamber (AC) cells in study eyes measured on a scale of 0-4.

  • Pain Scale [ Time Frame: Over all study visits - through postoperative day 15 +/- 1 day ] [ Designated as safety issue: No ]
    eye pain measured on a visual analog scale.

  • Resolution of anterior chamber (AC) flare [ Time Frame: Over all study visits - through postoperative day 15 +/- 1 day ] [ Designated as safety issue: No ]
    Scattering of a slit lamp light beam when directed into the AC (Tyndall effect). Tyndall effect measured on a scale of 0-4.


Enrollment: 250
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mapracorat
Ophthalmic suspension 3%
Drug: Mapracorat
Instill study medication into study eye per dosing instructions for 14 days
Other Name: BOL-303242-X
Placebo Comparator: Vehicle
Vehicle of mapracorat ophthalmic suspension
Drug: Vehicle
Instill study medication into the study eye per dosing instructions for 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who are candidates for routine, uncomplicated cataract surgery
  • Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
  • Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

  • Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
  • Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
  • Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
  • Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
  • Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230125

Locations
United States, New York
Bausch & Lomb, Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Rabia Ozden, MD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01230125     History of Changes
Other Study ID Numbers: 663
Study First Received: October 25, 2010
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bausch & Lomb Incorporated:
Inflammation
Pain
Ocular surgery

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014