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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01060072
First received: January 29, 2010
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Inflammation
Pain
 Drug: Loteprednol etabonate
Drug: Vehicle of 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
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

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Resolution of Anterior Chamber Cells. [ Time Frame: Visit 5 (Postoperative day 8) ] [ Designated as safety issue: No ]
    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

  • Grade 0 Pain [ Time Frame: Visit 5 (Postoperative day 8) ] [ Designated as safety issue: No ]
    Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain


Secondary Outcome Measures:
  • Resolution of Anterior Chamber Cells [ Time Frame: Visit 4-7 (postoperative day 3-18) ] [ Designated as safety issue: No ]
    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

  • Grade 0 Pain [ Time Frame: Visits 4-7 (Postoperative days 3-18) ] [ Designated as safety issue: No ]
    Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain

  • Resolution of Anterior Chamber Flare [ Time Frame: Visit 4-7 (postoperative day 3-18) ] [ Designated as safety issue: No ]
    Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe.


Enrollment: 407
Study Start Date: February 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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.

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01060072     History of Changes
Other Study ID Numbers: 577
Study First Received: January 29, 2010
Results First Received: September 20, 2011
Last Updated: December 8, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
 Loteprednol etabonate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013