Safety and Efficacy of Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle for the Treatment of Inflammation Following Cataract Surgery - Full Text View

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00645671

Purpose

To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Condition	Intervention	Phase
Ocular Inflammation	Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus 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:

Proportion of subjects with complete resolution of anterior chamber cells and flare [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with complete resolution of inflammation at each visit [ Time Frame: At 4 visits ] [ Designated as safety issue: No ]
Change from baseline in inflammation [ Time Frame: At 4 visits ] [ Designated as safety issue: No ]
Safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

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

Arms	Assigned Interventions
1: Experimental	Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment 1/2 inch ribbon qid 14 days
2: Placebo Comparator	Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment 1/2 inch ribbon qid 14 days

Eligibility

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

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645671

Locations

United States, Kansas
John Hunkeler, MD
Overland Park, Kansas, United States

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators

Study Director:

Alyson J Berliner, MD/PhD

Bausch & Lomb, Inc.

More Information

No publications provided

Responsible Party:	Bausch and Lomb, Inc. ( Marcia de Souza Lima, MD )
Study ID Numbers:	525
Study First Received:	March 13, 2008
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00645671 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 September 10, 2009