Status:
COMPLETED
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Ocular Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.
Eligibility Criteria
Inclusion
- Subjects at least 18 years of age
- Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Subjects who are candidate for routine, uncomplicated cataract surgery.
- Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
- Subjects must be willing and able to comply with all treatment and follow- up procedures.
Exclusion
- Subjects who have known hypersensitivity or contraindication to the study drug or its components.
- Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
- Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
- Subjects with elevated intraocular pressure (\>/= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
- Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
- Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
- Women who are pregnant or breast feeding.
- Subjects who have participated in an investigational drug or device study within the last 30 days.
- Subjects previously randomized in this study.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00699153
Start Date
June 1 2008
End Date
June 1 2009
Last Update
March 24 2015
Active Locations (1)
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1
Cornerstone Eye Wear
High Point, North Carolina, United States, 27262