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

This study is ongoing, but not recruiting participants.

First Received: June 13, 2008 Last Updated: May 22, 2009 History of Changes

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00699153

Purpose

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.

Condition	Intervention	Phase
Ocular Inflammation	Drug: Loteprednol Etabonate Drug: Vehicle of Ophthalmic Loteprednol Etabonate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract Surgery

Drug Information available for: Loteprednol etabonate Loteprednol

U.S. FDA Resources

Further study details as provided by Bausch & Lomb, Inc.:

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 ]

Estimated Enrollment:	400
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Loteprednol Etabonate	Drug: Loteprednol Etabonate Loteprednol Etabonate in an ophthalmic base will be administered to study eye QID for 14 days.
2: Placebo Comparator Vehicle of Ophthalmic Loteprednol Etabonate	Drug: Vehicle of Ophthalmic Loteprednol Etabonate Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye QID for 14 days.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699153

Locations

United States, North Carolina
Cornerstone Eye Wear
High Point, North Carolina, United States, 27262

Sponsors and Collaborators

Bausch & Lomb, Inc.

More Information

No publications provided

Responsible Party:	Bausch & Lomb Incorporated ( Susan Schneider MD )
Study ID Numbers:	526
Study First Received:	June 13, 2008
Last Updated:	May 22, 2009
ClinicalTrials.gov Identifier:	NCT00699153 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cataract
Anti-Allergic Agents
Loteprednol etabonate
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Anti-Allergic Agents

Loteprednol etabonate
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on August 28, 2009