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

NCT01928693 | Terminated Phase 2 Results

• 1 other identifier: Eye02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Ulcers

Keywords

infectious corneal ulcers

Outcome Measures

Primary Outcomes (1)

• Complete Healing

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

  29 days

Secondary Outcomes (1)

• Healing Rate

  29 days

Other Outcomes (5)

• Time to Treatment Failure.

  8 days

• Scarring

  29 days

• Patient Satisfaction Scores

  Average of 6 times in a 29 day period

Study Arms (3)

Besivance 0.6% Ophthalmic Suspension

ACTIVE COMPARATOR

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

Drug: Besivance 0.6% Ophthalmic Suspension

Zymaxid 0.5% Ophthalmic Solution

ACTIVE COMPARATOR

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

Drug: Zymaxid 0.5% Ophthalmic Solution

Vigamox 0.5% Ophthalmic Solution

ACTIVE COMPARATOR

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

Drug: Vigamox 0.5% Ophthalmic Solution

Interventions

Besivance 0.6% Ophthalmic Suspension 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.

Also known as: Besifloxacin 0.6% Ophthalmic Suspension

Besivance 0.6% Ophthalmic Suspension

Zymaxid 0.5% Ophthalmic Solution 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.

Also known as: Gatifloxacin 0.5% Ophthalmic Solution

Zymaxid 0.5% Ophthalmic Solution

Vigamox 0.5% Ophthalmic Solution 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.

Also known as: Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution

Vigamox 0.5% Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cornea Consultants Of Nashville: lead
• SCRI Development Innovations, LLC: collaborator
• Bausch & Lomb Incorporated: collaborator

Study Sites (1)

Cornea Consultants of Nashville

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Corneal Ulcer

Interventions

besifloxacin; Gatifloxacin; Ophthalmic Solutions; Moxifloxacin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Limitations and Caveats

The study was terminated due to slow enrollment.

Results Point of Contact

• Title: Ira Shivitz MD
• Organization: Cornea Consultants of Nashville

jhatley@corneaconsultants.net

615-320-7200

Study Officials

• Ira A. Shivitz, M.D.

  Cornea Consultants Of Nashville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 27, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 13, 2015
• Results First Posted: August 13, 2015

Record last verified: 2015-08

Locations

US (1)