Title
A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.
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.
Phase
Phase 2Lead Sponsor
Cornea Consultants Of NashvilleStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Corneal UlcersIntervention/Treatment
besifloxacin gatifloxacin moxifloxacin ...Study Participants
2This 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.
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.
Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Inclusion Criteria: Patients must be between the ages of 18-90 years of age. Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements. Patients must have a corneal ulcer greater than 2mm but less than 6mm in size. Patients must have corneal ulcer present in only one eye. Patients must agree not to wear contact lenses while on study. Exclusion Criteria: Patients with multifocal ulcers. Signs of any other viral or fungal infection. Treatment with antibiotics within 14 days of study entry. 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. 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%). Contact lens only with no spectacles available. Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study. Participation in any investigational study within the past 30 days. Pregnant women, minors, or those not able to consent for themselves.
| Event Type | Organ System | Event Term |
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The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.
Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.
If there is no reduction in size of the corneal ulcer by day 8, the treatment will be deemed a failure and alternative medications will be given at the discretion of the investigator.
Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.
Patient satisfaction outcomes will be assessed using a series of survey questions ranging in both categorical and continuous outcomes. Treatment will be compared using either methods for differences in binomial proportions or the Wilcoxon Rank Sum test. Scale= 0- Very Comfortable, 1- Comfortable, 2- Uncomfortable, 3- Very Uncomfortable
Patients will be asked to grade the overall pain of the affected eye at each visit on a Scale= 0--None, 1- Mild, 2- Moderate, 3- Severe
