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

Phase 2

Terminated

• Conditions: Corneal Ulcers
• Interventions: Drug: Vigamox 0.5% Ophthalmic Solution; Drug: Besivance 0.6% Ophthalmic Suspension; Drug: Zymaxid 0.5% Ophthalmic Solution

• Registration Number: NCT01928693
• Lead Sponsor: Cornea Consultants Of Nashville

Brief 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.

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-20
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-27
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-08
• Results First Submitted: 2015-08-11
• Results First Submitted QC: 2015-08-11
• Last Update Submitted: 2015-08-11
• Results First Posted: 2015-08-13
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vigamox 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.
Besivance 0.6% Ophthalmic Suspension	Besivance 0.6% Ophthalmic Suspension	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.
Zymaxid 0.5% Ophthalmic Solution	Zymaxid 0.5% Ophthalmic Solution	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.

Primary Outcome Measures

Name	Time	Method
Complete Healing	29 days	The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.

Secondary Outcome Measures

Name	Time	Method
Healing Rate	29 days	Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.

Trial Locations

Locations (1)

Cornea Consultants of Nashville; 🇺🇸 Nashville, Tennessee, United States