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

Information source: Cornea Consultants Of Nashville
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Corneal Ulcers

Intervention: Besivance 0.6% Ophthalmic Suspension (Drug); Zymaxid 0.5% Ophthalmic Solution (Drug); Vigamox 0.5% Ophthalmic Solution (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Cornea Consultants Of Nashville

Official(s) and/or principal investigator(s):
Ira A. Shivitz, M.D., Principal Investigator, Affiliation: Cornea Consultants Of Nashville


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.

Clinical Details

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 Corneal Ulcers.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Complete Healing

Secondary outcome: Healing Rate

Detailed description: 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.


Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.


Inclusion Criteria: 1. Patients must be between the ages of 18-90 years of age. 2. Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements. 3. Patients must have a corneal ulcer greater than 2mm but less than 6mm in size. 4. Patients must have corneal ulcer present in only one eye. 5. Patients must agree not to wear contact lenses while on study. Exclusion Criteria: 1. Patients with multifocal ulcers. 2. Signs of any other viral or fungal infection. 3. Treatment with antibiotics within 14 days of study entry. 4. Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular nonsteroidal anti-inflammatory drugs (NSAIDS) during the prior 14-day period. 5. Known hypersensitivity or allergy to steroids (Loteprednol etabonate) or to any of the ingredients in the three study drugs (Besifloxacin 0. 6% or Gatifloxacin 0. 5% or Moxifloxacin 0. 5%). 6. Contact lens only with no spectacles available. 7. Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study. 8. Participation in any investigational study within the past 30 days. 9. Pregnant women, minors, or those not able to consent for themselves.

Locations and Contacts

Cornea Consultants of Nashville, Nashville, Tennessee 37203, United States
Additional Information

Starting date: July 2013
Last updated: August 11, 2015

Page last updated: August 23, 2015

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