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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928693
Recruitment Status : Terminated (study terminated due to slow accrual)
First Posted : August 27, 2013
Results First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Collaborators:
SCRI Development Innovations, LLC
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Corneal Ulcers Drug: Besivance 0.6% Ophthalmic Suspension Drug: Zymaxid 0.5% Ophthalmic Solution Drug: Vigamox 0.5% Ophthalmic Solution Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : July 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution




Primary Outcome Measures :
  1. Complete Healing [ Time Frame: 29 days ]
    The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.


Secondary Outcome Measures :
  1. Healing Rate [ Time Frame: 29 days ]
    Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.


Other Outcome Measures:
  1. Time to Treatment Failure. [ Time Frame: 8 days ]
    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.

  2. Scarring [ Time Frame: 29 days ]
    Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.

  3. Patient Satisfaction Scores [ Time Frame: Average of 6 times in a 29 day period ]
    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

  4. Patient Pain Scores [ Time Frame: Average of 6 times in a 29 day period ]
    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

  5. Number of Participants With Treatment Failure [ Time Frame: 29 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928693


Locations
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United States, Tennessee
Cornea Consultants of Nashville
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Cornea Consultants Of Nashville
SCRI Development Innovations, LLC
Bausch & Lomb Incorporated
Investigators
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Principal Investigator: Ira A. Shivitz, M.D. Cornea Consultants Of Nashville
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Responsible Party: Cornea Consultants Of Nashville
ClinicalTrials.gov Identifier: NCT01928693    
Other Study ID Numbers: Eye02
First Posted: August 27, 2013    Key Record Dates
Results First Posted: August 13, 2015
Last Update Posted: August 13, 2015
Last Verified: August 2015
Keywords provided by Cornea Consultants Of Nashville:
infectious corneal ulcers
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Corneal Ulcer
Ulcer
Pathologic Processes
Eye Infections
Keratitis
Corneal Diseases
Eye Diseases
Moxifloxacin
Gatifloxacin
Besifloxacin
Pharmaceutical Solutions
Ophthalmic Solutions
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs