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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014