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

NCT01928693 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-08-13

Study results available
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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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • SCRI Development Innovations, LLC

    collaborator OTHER

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • Cornea Consultants Of Nashville

    lead OTHER

Principal Investigators

  • Ira A. Shivitz, M.D. · Cornea Consultants Of Nashville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01928693 on ClinicalTrials.gov