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

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ClinicalTrials.gov Identifier: NCT01060072
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : January 13, 2012
Last Update Posted : January 13, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Study Start Date : February 2010
Primary Completion Date : September 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Loteprednol etabonate
Loteprednol etabonate 0.5% ophthalmic suspension
Drug: Loteprednol etabonate
Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.
Placebo Comparator: Vehicle
Vehicle of loteprednol etabonate ophthalmic suspension
Drug: Vehicle of Loteprednol Etabonate
Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.


Outcome Measures

Primary Outcome Measures :
  1. Resolution of Anterior Chamber Cells. [ Time Frame: Visit 5 (Postoperative day 8) ]
    Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells

  2. Grade 0 Pain [ Time Frame: Visit 5 (Postoperative day 8) ]
    Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain


Secondary Outcome Measures :
  1. Resolution of Anterior Chamber Cells [ Time Frame: Visit 4-7 (postoperative day 3-18) ]
    Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells

  2. Grade 0 Pain [ Time Frame: Visits 4-7 (Postoperative days 3-18) ]
    Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain

  3. Resolution of Anterior Chamber Flare [ Time Frame: Visit 4-7 (postoperative day 3-18) ]
    Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.


Eligibility Criteria

Information from the National Library of Medicine

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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.

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 visual acuity (VA) 20/200 or worse in the non-study eye.
Contacts and Locations

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): NCT01060072


Locations
United States, New York
Bausch & Lomb
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):
Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01060072     History of Changes
Other Study ID Numbers: 577
First Posted: February 2, 2010    Key Record Dates
Results First Posted: January 13, 2012
Last Update Posted: January 13, 2012
Last Verified: December 2011

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Loteprednol Etabonate
Anti-Allergic Agents