Status:
COMPLETED
Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 catarac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT01230125
Start Date
November 1 2010
End Date
August 1 2011
Last Update
September 3 2020
Active Locations (1)
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1
Bausch & Lomb, Incorporated
Rochester, New York, United States, 14609