Corneal Ulcers
Conditions
Keywords
infectious corneal ulcers
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.
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.
Interventions
DRUGBesivance 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.
DRUGZymaxid 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.
DRUGVigamox 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
SCRI Development Innovations, LLC
Bausch & Lomb Incorporated
Cornea Consultants Of Nashville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Healing | 29 days | The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing Rate | 29 days | Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Number of Participants With Treatment Failure | 29 days | — |
| 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 |
| Scarring | 29 days | Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 1 |
| 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. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Zymaxid 0.5% Ophthalmic Solution | Vigamox 0.5% Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 participants | 0 participants | 0 participants |
| Age, Categorical >=65 years | 1 participants | 0 participants | 1 participants |
| Age, Categorical Between 18 and 65 years | 0 participants | 1 participants | 1 participants |
| Gender Female | 1 participants | 0 participants | 1 participants |
| Gender Male | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 1 participants | 1 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 | 0 / 1 |
Outcome results
Primary
Complete Healing
The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29.
Time frame: 29 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zymaxid 0.5% Ophthalmic Solution | Complete Healing | 1 participant |
| Vigamox 0.5% Ophthalmic Solution | Complete Healing | 1 participant |
Secondary
Healing Rate
Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days.
Time frame: 29 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zymaxid 0.5% Ophthalmic Solution | Healing Rate | 21 Days |
| Vigamox 0.5% Ophthalmic Solution | Healing Rate | 21 Days |
Other Pre-specified
Number of Participants With Treatment Failure
Time frame: 29 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zymaxid 0.5% Ophthalmic Solution | Number of Participants With Treatment Failure | 0 participants |
| Vigamox 0.5% Ophthalmic Solution | Number of Participants With Treatment Failure | 0 participants |
Other Pre-specified
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
Time frame: Average of 6 times in a 29 day period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zymaxid 0.5% Ophthalmic Solution | Patient Pain Scores | 0 units on a scale |
| Vigamox 0.5% Ophthalmic Solution | Patient Pain Scores | 2 units on a scale |
Other Pre-specified
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
Time frame: Average of 6 times in a 29 day period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zymaxid 0.5% Ophthalmic Solution | Patient Satisfaction Scores | 0 units on a scale |
| Vigamox 0.5% Ophthalmic Solution | Patient Satisfaction Scores | 2 units on a scale |
Other Pre-specified
Scarring
Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.
Time frame: 29 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zymaxid 0.5% Ophthalmic Solution | Scarring | 0 millimeters |
| Vigamox 0.5% Ophthalmic Solution | Scarring | 0 millimeters |
Other Pre-specified
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.
Time frame: 8 days
Population: Data was not collected because there were no treatment failures in any of the treatment arms