Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 13, 2008

Last Updated Date

January 12, 2009

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

The proportion of subjects with complete resolution of anterior chamber cells and flare. [ Time Frame: Postoperative day 8 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699153 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Official Title ^†

Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Ocular Inflammation

Intervention ^†

Drug: Loteprednol Etabonate
Drug: Vehicle of Ophthalmic Loteprednol Etabonate

Study Arms / Comparison Groups

Experimental: Loteprednol Etabonate
Placebo Comparator: Vehicle of Ophthalmic Loteprednol Etabonate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

400

Estimated Completion Date

March 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

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 Criteria:

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Kelley A. O'Donoghue, MPH

585-338-6484

kelley_odonoghue@bausch.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699153

Responsible Party

Marcia de Souza Lima, MD, Bausch & Lomb Incorporated

Secondary IDs ^††

Study Sponsor ^†

Bausch & Lomb, Inc.

Collaborators ^††

Investigators ^†

Information Provided By

Bausch & Lomb, Inc.

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.