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

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. Participants from the United States and Canada will be recruited for this study.

Condition	Intervention	Phase
Cataract Inflammation Surgery	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:	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:

MedlinePlus related topics: Cataract

U.S. FDA Resources

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 flare measured on a scale of 0-4 where 0= none and 4=very severe.
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)

Estimated Enrollment:	300
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	September 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 four times daily (QID) for 14 days
Placebo Comparator: Vehicle The vehicle of the mapracorat ophthalmic suspension	Drug: Vehicle 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: NCT01591655

Contacts

Contact: Colleen McCallum, MBA

(585) 338-6048

Colleen.McCallum@bausch.com

Locations

United States, New York
Bausch & Lomb, Incorporated	Recruiting
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:	NCT01591655 History of Changes
Other Study ID Numbers:	793
Study First Received:	May 2, 2012
Last Updated:	May 14, 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 May 16, 2013