Clinical Trial: A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Single-site, Single Masked, Prospective Comparison of Three Fluoroquinolone Topical Therapies (Besifloxacin 0.6% or Gatifloxacin 0.5% or Moxifloxacin 0.5%) in the Treatment of Infectious

Brief Summary: This Phase II study will evaluate the safety and efficacy of three fluoroquinolone ophthalmic agents to determine the optimal treatment in patients with infectious corneal ulcers.

Detailed Summary: This is a prospective, single masked, comparative, mono-therapeutic trial evaluating three fluoroquinolone agents that are approved and marketed for the treatment of conjunctivitis. Approximately 120 patients who have corneal ulcers greater than 2 mm but less than 6 mm in size who meet all other inclusion criteria will be enrolled into this study. Patients will be randomized in a 2:1:1 ratio to receive besifloxacin 0.6% ophthalmic suspension, gatifloxacin 0.5% ophthalmic solution, or moxifloxacin 0.5% ophthalmic solution.
Sponsor: Cornea Consultants Of Nashville

Current Primary Outcome: Complete Healing [ Time Frame: 29 days ]

The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.


Original Primary Outcome: Same as current

Current Secondary Outcome: Healing Rate [ Time Frame: 29 days ]

Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.


Original Secondary Outcome: Healing Rate [ Time Frame: 21 days ]

Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.


Information By: Cornea Consultants Of Nashville

Dates:
Date Received: August 20, 2013
Date Started: July 2013
Date Completion:
Last Updated: August 11, 2015
Last Verified: August 2015