Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01591161
First received: May 2, 2012
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% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Condition Intervention Phase
Cataract
Inflammation
Surgery
Drug: Mapracorat
Drug: Placebo
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: The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • AC Cells [ Time Frame: Visit 5 (post-operative day 8) ] [ Designated as safety issue: No ]
    Proportion of subjects with complete resolution of anterior chamber (AC) cells in the study eye at Visit 5 (Postoperative Day 8) for mapracorat and vehicle. AC cells measured on a scale of 0-4 where 0=no cells and 4=>30 cells.

  • Pain [ Time Frame: Visit 5 (post-operative day 8) ] [ Designated as safety issue: No ]
    Proportion of subjects with Grade 0 pain in the study eye at Visit 5 (Postoperative Day 8) for mapracorat and vehicle. Pain measured on a scale of 0-5 where 0=no pain and 5=severe pain.


Secondary Outcome Measures:
  • AC Cells [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with complete resolution of AC cells in the study eye at each visit and for each subject's final on-treatment visit. AC cells measured on a scale of 0-4 where 0=no cells and 4=>30 cells.

  • Pain [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with Grade 0 pain in the study eye at each visit and for each subject's final on-treatment visit. Pain measured on a scale of 0-5 where 0=no pain and 5=severe pain.

  • AC Flare [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with complete resolution of AC flare in the study eye at each visit and for each subject's final on-treatment visit.

  • AC Cells & Flare [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with complete resolution of AC cells and flare in the study eye at each visit and for each subject's final on-treatment visit.

  • Change from Baseline AC Cells & Flare [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Change from baseline at each follow-up visit in AC cells and AC flare combined and separately.

  • Treatment Failures [ Time Frame: Visit 5 (Postoperative Day 8) ] [ Designated as safety issue: No ]
    Proportion of treatment failures at Visit 5 (Postoperative Day 8)


Enrollment: 369
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mapracorat
Mapracorat ophthalmic suspension, 3%,
Drug: Mapracorat
1 drop of study medication into the study eye QID for 14 days
Placebo Comparator: Vehicle
The vehicle of the mapracorat ophthalmic suspension
Drug: Placebo
1 drop of vehicle into the study eye QID for 14 days.

  Eligibility

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

Inclusion Criteria:

  • Subjects who are candidates for routine, uncomplicated cataract surgery.
  • Subjects who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
  • Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).

Exclusion Criteria:

  • Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
  • Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
  • Presence of active external ocular disease: infection or inflammation of the study eye.
  • Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
  • Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591161

Locations
United States, New York
Bausch & Lomb Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Quintus Ngumah, OD, PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01591161     History of Changes
Other Study ID Numbers: 790
Study First Received: May 2, 2012
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014