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Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

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ClinicalTrials.gov Identifier: NCT01010633
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : January 9, 2012
Last Update Posted : January 9, 2012
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammation Pain Drug: Vehicle of Loteprednol Etabonate Drug: Loteprednol Etabonate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Resolution of Anterior Chamber Cells (ACC). [ Time Frame: Visit 5 (Postoperative day 8) ]
    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.

  2. Grade 0 Pain [ Time Frame: Visit 5 (Postoperative Day 8) ]
    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 :
  1. Resolution of Anterior Chamber Cells. [ Time Frame: At visits 4-7- postoperative day 3, 8,15 & 18 ]
    Study eyes with complete resolution of anterior chamber cells (ACC)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01010633     History of Changes
Other Study ID Numbers: 576
First Posted: November 10, 2009    Key Record Dates
Results First Posted: January 9, 2012
Last Update Posted: January 9, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Loteprednol Etabonate
Anti-Allergic Agents