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

• Sponsor: Cornea Consultants Of Nashville (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01928693
• Collaborator: SCRI Development Innovations, LLC (Other), Bausch & Lomb Incorporated (Industry)
• Enrollment: 2
• Location: 1
• Arms: 3
• Duration (Months): 10
• Patients Per Site Per Month: 0.2

Study Details

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.

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.

Study Design

• Study Type: Interventional
• 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: Jul 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

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 Names: 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 Names: 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 Names: Moxifloxacin Hydrochloride 0.5% Ophthalmic Solution

Outcome Measures

Primary Outcome Measures

1. Complete Healing [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 [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. [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 [29 days]

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

3. Patient Satisfaction Scores [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 [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 [29 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cornea Consultants of Nashville	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ira A. Shivitz, M.D., Cornea Consultants Of Nashville

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cornea Consultants Of Nashville
• ClinicalTrials.gov Identifier: NCT01928693
• Other Study ID Numbers: Eye02
• First Posted: Aug 27, 2013
• Last Update Posted: Aug 13, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Cornea Consultants Of Nashville: infectious corneal ulcers
• Additional relevant MeSH terms: Communicable Diseases; Infections; Corneal Ulcer; Ulcer; Moxifloxacin; Gatifloxacin; Besifloxacin; Pharmaceutical Solutions; Ophthalmic Solutions; Norgestimate, ethinyl estradiol drug combination

Study Results

Participant Flow

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
Period Title: Overall Study
STARTED	0	1	1
COMPLETED	0	1	1
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution	Total
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	Total of all reporting groups
Overall Participants	0	1	1	2
Age (participants) [Number]
<=18 years	0 NaN	0 0%	0 0%
Between 18 and 65 years	0 NaN	1 100%	1 100%
>=65 years	1 Infinity	0 0%	1 100%
Gender (participants) [Number]
Female	1 Infinity	0 0%	1 100%
Male	0 NaN	1 100%	1 100%
Region of Enrollment (participants) [Number]
United States	1 Infinity	1 100%	2 200%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
Measure Participants	0	1	1
Number [participant]	1	1

2. Secondary Outcome

Title	Healing Rate
Description	Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.
Time Frame	29 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
Measure Participants	0	1	1
Number [Days]	21	21

3. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

Data was not collected because there were no treatment failures in any of the treatment arms

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
Measure Participants	0	0	0

4. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
Measure Participants	0	1	1
Number [millimeters]	0	0

5. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
Measure Participants	0	1	1
Number [units on a scale]	0	2

6. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
Measure Participants	0	1	1
Number [units on a scale]	0	2

7. Other Pre-specified Outcome

Title	Number of Participants With Treatment Failure
Time Frame	29 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Besivance 0.6% Ophthalmic Suspension	Zymaxid 0.5% Ophthalmic Solution	Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.	A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
Measure Participants	0	1	1
Number [participants]	0 NaN	0 0%

Adverse Events

Time Frame	29 days
Arm/Group Title	Besivance 0.6% Ophthalmic Suspension		Zymaxid 0.5% Ophthalmic Solution		Vigamox 0.5% Ophthalmic Solution
Arm/Group Description	A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. 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.		A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.		A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. 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.
All Cause Mortality
	Besivance 0.6% Ophthalmic Suspension		Zymaxid 0.5% Ophthalmic Solution		Vigamox 0.5% Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Besivance 0.6% Ophthalmic Suspension		Zymaxid 0.5% Ophthalmic Solution		Vigamox 0.5% Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Besivance 0.6% Ophthalmic Suspension		Zymaxid 0.5% Ophthalmic Solution		Vigamox 0.5% Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/1 (0%)		0/1 (0%)

Limitations/Caveats

The study was terminated due to slow enrollment.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.