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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 2010

Interventions

  • Drug: Vehicle of Loteprednol Etabonate
    • 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.
  • Drug: Loteprednol Etabonate
    • 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.

Arms, Groups and Cohorts

  • Experimental: Loteprednol Etabonate
    • Loteprednol etabonate
  • Placebo Comparator: Vehicle
    • Vehicle of loteprednol etabonate

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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 Measures

  • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Laura Trusso, Study Director, Bausch & Lomb Incorporated

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