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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01591161
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Inflammation Surgery Drug: Mapracorat Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2012
Primary Completion Date : June 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. AC Cells [ Time Frame: Visit 5 (post-operative day 8) ]
    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.

  2. Pain [ Time Frame: Visit 5 (post-operative day 8) ]
    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 :
  1. AC Cells [ Time Frame: 2 weeks ]
    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.

  2. Pain [ Time Frame: 2 weeks ]
    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.

  3. AC Flare [ Time Frame: 2 weeks ]
    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.

  4. AC Cells & Flare [ Time Frame: 2 weeks ]
    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.

  5. Change from Baseline AC Cells & Flare [ Time Frame: 2 weeks ]
    Change from baseline at each follow-up visit in AC cells and AC flare combined and separately.

  6. Treatment Failures [ Time Frame: Visit 5 (Postoperative Day 8) ]
    Proportion of treatment failures at Visit 5 (Postoperative Day 8)


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01591161     History of Changes
Other Study ID Numbers: 790
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: November 2013

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