Trial Outcomes & Findings for A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers. (NCT NCT01928693)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

29 days

Results posted on

2015-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Zymaxid 0.5% Ophthalmic Solution 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.	Vigamox 0.5% Ophthalmic Solution 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.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Besivance 0.6% Ophthalmic Suspension 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.	Zymaxid 0.5% Ophthalmic Solution n=1 Participants 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.	Vigamox 0.5% Ophthalmic Solution n=1 Participants 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 n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Age, Categorical >=65 years	—	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Gender Female	—	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants
Gender Male	—	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants

PRIMARY outcome

Timeframe: 29 days

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

Outcome measures

Outcome measures
Measure	Besivance 0.6% Ophthalmic Suspension 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.	Zymaxid 0.5% Ophthalmic Solution n=1 Participants 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.	Vigamox 0.5% Ophthalmic Solution n=1 Participants 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.
Complete Healing	—	1 participant	1 participant

SECONDARY outcome

Timeframe: 29 days

Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.

Outcome measures

Outcome measures
Measure	Besivance 0.6% Ophthalmic Suspension 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.	Zymaxid 0.5% Ophthalmic Solution n=1 Participants 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.	Vigamox 0.5% Ophthalmic Solution n=1 Participants 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.
Healing Rate	—	21 Days	21 Days

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 days

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

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 29 days

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

Outcome measures

Outcome measures
Measure	Besivance 0.6% Ophthalmic Suspension 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.	Zymaxid 0.5% Ophthalmic Solution n=1 Participants 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.	Vigamox 0.5% Ophthalmic Solution n=1 Participants 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.
Scarring	—	0 millimeters	0 millimeters

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Besivance 0.6% Ophthalmic Suspension 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.	Zymaxid 0.5% Ophthalmic Solution n=1 Participants 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.	Vigamox 0.5% Ophthalmic Solution n=1 Participants 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.
Patient Satisfaction Scores	—	0 units on a scale	2 units on a scale

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Besivance 0.6% Ophthalmic Suspension 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.	Zymaxid 0.5% Ophthalmic Solution n=1 Participants 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.	Vigamox 0.5% Ophthalmic Solution n=1 Participants 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.
Patient Pain Scores	—	0 units on a scale	2 units on a scale

OTHER_PRE_SPECIFIED outcome

Timeframe: 29 days

Outcome measures

Outcome measures
Measure	Besivance 0.6% Ophthalmic Suspension 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.	Zymaxid 0.5% Ophthalmic Solution n=1 Participants 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.	Vigamox 0.5% Ophthalmic Solution n=1 Participants 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.
Number of Participants With Treatment Failure	—	0 participants	0 participants

Adverse Events

Besivance 0.6% Ophthalmic Suspension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Zymaxid 0.5% Ophthalmic Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vigamox 0.5% Ophthalmic Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ira Shivitz MD

Cornea Consultants of Nashville

Phone: 615-320-7200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place