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

Phase 3TerminatedNCT01298752

Bausch & Lomb Incorporated177 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

177

Conditions

Inflammation Pain Cataract

Interventions

MapracoratDRUG

Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.

VehicleDRUG

Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bausch & Lomb Incorporated

Rochester, New York, United States

Outcomes

Primary Outcomes

Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.

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.

Time frame: 8 days

Percentage of Participants With Grade 0 Pain

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.

Time frame: 8 days

Data from ClinicalTrials.gov

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