Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery | NCT01010633 | Trialant
CompletedInterventionalPhase 3Updated Jan 9, 2012
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
ClinicalTrials.gov ID
NCT01010633
Lead Sponsor
Bausch & Lomb IncorporatedINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
406Actual
Last Update Posted
Jan 9, 2012Estimated
Start Date
Nov 2009
Primary Completion Date
Jun 2010Actual
Completion Date
Aug 2010Actual
Brief Summary
This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Inflammation
Pain
Vehicle of Loteprednol Etabonate
Loteprednol Etabonate
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who are at least 18 years of age.
Subjects who are candidates 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 Criteria:
Subjects who have known hypersensitivity or contraindication to the study drug or components.
Subjects with 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 (>/= 21mm 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.