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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-08-31

Brief Summary

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The objective of this clinical 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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mapracorat

Ophthalmic suspension 3%

Group Type EXPERIMENTAL

Mapracorat

Intervention Type DRUG

Instill study medication into study eye per dosing instructions for 14 days

Vehicle

Vehicle of mapracorat ophthalmic suspension

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Instill study medication into the study eye per dosing instructions for 14 days

Interventions

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Mapracorat

Instill study medication into study eye per dosing instructions for 14 days

Intervention Type DRUG

Vehicle

Instill study medication into the study eye per dosing instructions for 14 days

Intervention Type DRUG

Other Intervention Names

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BOL-303242-X

Eligibility Criteria

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Inclusion Criteria

* Participants who are candidates for routine, uncomplicated cataract surgery
* Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
* Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria

* Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
* Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
* Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
* Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No