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

Corneal Ulcers Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01928693
• Other study ID #: Eye02
• Status: Terminated
• Phase: Phase 2
• First received: August 20, 2013
• Last updated: August 11, 2015
• Start date: July 2013
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: Cornea Consultants Of Nashville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Corneal Ulcer
• Corneal Ulcers
• Infection
• Ulcer

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cornea Consultants of Nashville	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Cornea Consultants Of Nashville	Bausch & Lomb Incorporated, SCRI Development Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Scarring	Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.	29 days	No
Other	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	No
Other	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	No
Other	Number of Participants With Treatment Failure		29 days	No
Primary	Complete Healing	The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.	29 days	No
Secondary	Healing Rate	Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.	29 days	No