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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Corneal Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Besivance 0.6% Ophthalmic Suspension

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

Group Type ACTIVE_COMPARATOR

Besivance 0.6% Ophthalmic Suspension

Intervention Type DRUG

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.

Zymaxid 0.5% Ophthalmic Solution

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

Group Type ACTIVE_COMPARATOR

Zymaxid 0.5% Ophthalmic Solution

Intervention Type DRUG

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.

Vigamox 0.5% Ophthalmic Solution

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

Group Type ACTIVE_COMPARATOR

Vigamox 0.5% Ophthalmic Solution

Intervention Type DRUG

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.

Interventions

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Besivance 0.6% Ophthalmic Suspension

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 Type DRUG

Zymaxid 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.

Intervention Type DRUG

Vigamox 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.

Intervention Type DRUG

Other Intervention Names

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Besifloxacin 0.6% Ophthalmic Suspension Gatifloxacin 0.5% Ophthalmic Solution Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No