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

Phase 3

Terminated

• Conditions: Inflammation; Pain; Cataract
• Interventions: Drug: Mapracorat; Drug: Vehicle

• Registration Number: NCT01298752
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Primary Completion: 2011-09
• Study Completion: 2011-11
• Disposition First Submitted: 2013-02-13
• Disposition First Submitted QC: 2013-02-13
• Disposition First Posted: 2013-02-15
• Status Verified: 2020-08
• Results First Submitted: 2020-08-18
• Results First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Results First Posted: 2020-09-03
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Subjects who are candidates for routine, uncomplicated cataract surgery.
• Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria

• Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
• Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mapracorat	Mapracorat	Mapracorat ophthalmic suspension
Vehicle	Vehicle	Vehicle of mapracorat ophthalmic suspension

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.	8 days	Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
Percentage of Participants With Grade 0 Pain	8 days	Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, where higher scores indicated worse pain.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States