Status:
COMPLETED
Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Ocular Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery
Eligibility Criteria
Inclusion
- Subjects who are candidate for routine, uncomplicated cataract surgery
- Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.
Exclusion
- Subjects who will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
- Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
- Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
- Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00645671
Start Date
March 1 2008
End Date
March 1 2009
Last Update
March 24 2015
Active Locations (1)
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1
John Hunkeler, MD
Overland Park, Kansas, United States, 66210