A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers. (Eye02)

Cornea Consultants Of Nashville

Status and phase: Terminated; Phase 2

Conditions: Corneal Ulcers

Treatments: Drug: Vigamox 0.5% Ophthalmic Solution; Drug: Besivance 0.6% Ophthalmic Suspension; Drug: Zymaxid 0.5% Ophthalmic Solution

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01928693

Eye02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 3 patient groups

Besivance 0.6% Ophthalmic Suspension

Active Comparator group

Description:

A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.

Treatment:

Drug: Besivance 0.6% Ophthalmic Suspension

Zymaxid 0.5% Ophthalmic Solution

Active Comparator group

Description:

A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

Treatment:

Drug: Zymaxid 0.5% Ophthalmic Solution

Vigamox 0.5% Ophthalmic Solution

Active Comparator group

Description:

A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

Treatment:

Drug: Vigamox 0.5% Ophthalmic Solution