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

Primary Purpose

Corneal Ulcers

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Besivance 0.6% Ophthalmic Suspension

Zymaxid 0.5% Ophthalmic Solution

Vigamox 0.5% Ophthalmic Solution

About this trial

This is an interventional treatment trial for Corneal Ulcers focused on measuring infectious corneal ulcers

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must be between the ages of 18-90 years of age.
Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements.
Patients must have a corneal ulcer greater than 2mm but less than 6mm in size.
Patients must have corneal ulcer present in only one eye.
Patients must agree not to wear contact lenses while on study.

Exclusion Criteria:

Patients with multifocal ulcers.
Signs of any other viral or fungal infection.
Treatment with antibiotics within 14 days of study entry.
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.
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%).
Contact lens only with no spectacles available.
Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study.
Participation in any investigational study within the past 30 days.
Pregnant women, minors, or those not able to consent for themselves.

Sites / Locations

Cornea Consultants of Nashville

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Besivance 0.6% Ophthalmic Suspension

Zymaxid 0.5% Ophthalmic Solution

Vigamox 0.5% Ophthalmic Solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

Complete Healing

The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.

Secondary Outcome Measures

Healing Rate

Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.

Full Information

NCT ID

NCT01928693

First Posted

August 20, 2013

Last Updated

August 11, 2015

Sponsor

Cornea Consultants Of Nashville

Collaborators

SCRI Development Innovations, LLC, Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01928693

Brief Title

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

Acronym

Eye02

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Terminated

Why Stopped

study terminated due to slow accrual

Study Start Date

July 2013 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cornea Consultants Of Nashville

Collaborators

SCRI Development Innovations, LLC, Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Corneal Ulcers

Keywords

infectious corneal ulcers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Besivance 0.6% Ophthalmic Suspension

Arm Type

Active Comparator

Arm Description

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

Arm Title

Zymaxid 0.5% Ophthalmic Solution

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vigamox 0.5% Ophthalmic Solution

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Besivance 0.6% Ophthalmic Suspension

Other Intervention Name(s)

Besifloxacin 0.6% Ophthalmic Suspension

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.

Intervention Type

Drug

Intervention Name(s)

Zymaxid 0.5% Ophthalmic Solution

Other Intervention Name(s)

Gatifloxacin 0.5% Ophthalmic Solution

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Vigamox 0.5% Ophthalmic Solution

Other Intervention Name(s)

Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution

Intervention Description

Primary Outcome Measure Information:

Title

Complete Healing

Description

The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.

Time Frame

29 days

Secondary Outcome Measure Information:

Title

Healing Rate

Description

Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.

Time Frame

29 days

Other Pre-specified Outcome Measures:

Title

Time to Treatment Failure.

Description

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.

Time Frame

8 days

Title

Scarring

Description

Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.

Time Frame

29 days

Title

Patient Satisfaction Scores

Description

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

Time Frame

Average of 6 times in a 29 day period

Title

Patient Pain Scores

Description

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

Time Frame

Average of 6 times in a 29 day period

Title

Number of Participants With Treatment Failure

Time Frame

29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be between the ages of 18-90 years of age. Patients must be able to understand the nature of this study, give written informed consent prior to study entry, and comply with study requirements. Patients must have a corneal ulcer greater than 2mm but less than 6mm in size. Patients must have corneal ulcer present in only one eye. Patients must agree not to wear contact lenses while on study. Exclusion Criteria: Patients with multifocal ulcers. Signs of any other viral or fungal infection. Treatment with antibiotics within 14 days of study entry. 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. 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%). Contact lens only with no spectacles available. Ocular surgery (including laser surgery) in either eye within 6 weeks prior to entry into this study. Participation in any investigational study within the past 30 days. Pregnant women, minors, or those not able to consent for themselves.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ira A. Shivitz, M.D.

Organizational Affiliation

Cornea Consultants Of Nashville

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cornea Consultants of Nashville

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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