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

NCT ID: NCT01591655

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-10-31

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

Conditions

Cataract; Inflammation; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mapracorat

Mapracorat ophthalmic suspension, 3%,

Group Type: EXPERIMENTAL

Mapracorat

Intervention Type: DRUG

1 drop of study medication into the study eye four times daily (QID) for 14 days

Vehicle

The vehicle of the mapracorat ophthalmic suspension

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

1 drop of vehicle into the study eye QID for 14 days.

Interventions

Mapracorat

1 drop of study medication into the study eye four times daily (QID) for 14 days

Intervention Type: DRUG

Vehicle

1 drop of vehicle into the study eye QID for 14 days.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quintus Ngumah, OD,PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb, Incorporated

Rochester, New York, United States

Countries

United States

Other Identifiers

793

Identifier Type: -

Identifier Source: org_study_id