A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.
Condition: Corneal Ulcers
MeSH terms: Communicable Diseases; Infections; Corneal Ulcer; Ulcer
Intervention: Besivance 0.6% Ophthalmic Suspension; Zymaxid 0.5% Ophthalmic Solution; Vigamox 0.5% Ophthalmic Solution
Intervention description: 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.
Intervention MeSH terms: Moxifloxacin; Gatifloxacin; Besifloxacin; Pharmaceutical Solutions; Ophthalmic Solutions; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: infectious corneal ulcers

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.
    

Eligibility criteria:

        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.