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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Corneal Ulcers
• Intervention / Treatment: Drug: Besivance 0.6% Ophthalmic Suspension; Drug: Zymaxid 0.5% Ophthalmic Solution; Drug: Vigamox 0.5% Ophthalmic Solution

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Cornea Consultants of Nashville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Besivance 0.6% Ophthalmic Suspension; A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.	Drug: 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.; Other Names: Besifloxacin 0.6% Ophthalmic Suspension
Active Comparator: Zymaxid 0.5% Ophthalmic Solution; A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.	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.; Other Names: Gatifloxacin 0.5% Ophthalmic Solution
Active Comparator: Vigamox 0.5% Ophthalmic Solution; A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.	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.; Other Names: Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Healing	The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.	29 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing Rate	Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.	29 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Treatment Failure.	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.	8 days
Scarring	Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.	29 days
Patient Satisfaction Scores	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	Average of 6 times in a 29 day period
Patient Pain Scores	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	Average of 6 times in a 29 day period
Number of Participants With Treatment Failure		29 days

Collaborators and Investigators

• Sponsor: Cornea Consultants Of Nashville
• Collaborators: Bausch & Lomb Incorporated; SCRI Development Innovations, LLC
• Investigators: Principal Investigator: Ira A. Shivitz, M.D., Cornea Consultants of Nashville

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: August 21, 2013
• First Posted (Estimate): August 27, 2013

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: infectious corneal ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Keratitis; Corneal Diseases; Eye Infections; Ulcer; Infections; Communicable Diseases; Corneal Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions; Pharmaceutical Solutions; Gatifloxacin; Besifloxacin
• Other Study ID Numbers: Eye02