Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Inflammation Pain	Drug: Vehicle of Loteprednol Etabonate Drug: Loteprednol Etabonate	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Loteprednol etabonate

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:

Resolution of Anterior Chamber Cells (ACC). [ Time Frame: Visit 5 (Postoperative day 8) ] [ Designated as safety issue: No ]
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Grade 0 Pain [ Time Frame: Visit 5 (Postoperative Day 8) ] [ Designated as safety issue: No ]
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.

Secondary Outcome Measures:

Resolution of Anterior Chamber Cells. [ Time Frame: At visits 4-7- postoperative day 3, 8,15 & 18 ] [ Designated as safety issue: No ]
Study eyes with complete resolution of anterior chamber cells (ACC)


Enrollment:	406
Study Start Date:	November 2009
Study Completion Date:	August 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Loteprednol Etabonate Loteprednol etabonate	Drug: Loteprednol Etabonate 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.
Placebo Comparator: Vehicle Vehicle of loteprednol etabonate	Drug: Vehicle of Loteprednol Etabonate 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010633

Locations


United States, New York
Bausch & Lomb, Inc.
Rochester, New York, United States, 14609

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators


Study Director:	Laura Trusso	Bausch & Lomb Incorporated

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rajpal RK, Fong R, Comstock TL. Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated analysis of two clinical studies. Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 18.


Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT01010633 History of Changes
Other Study ID Numbers:	576
Study First Received:	November 6, 2009
Results First Received:	August 30, 2011
Last Updated:	December 8, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Inflammation Pathologic Processes Loteprednol Etabonate Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 26, 2016