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study terminated due to slow accrual
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| Name | Class |
|---|---|
| SCRI Development Innovations, LLC | OTHER |
| Bausch & Lomb Incorporated | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Besivance 0.6% Ophthalmic Suspension | Active Comparator | A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis. |
|
| Zymaxid 0.5% Ophthalmic Solution | Active Comparator | A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. |
|
| Vigamox 0.5% Ophthalmic Solution | Active Comparator | A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Besivance 0.6% Ophthalmic Suspension | Drug | 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 | Description | Time Frame |
|---|---|---|
| Complete Healing | The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29. | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Healing Rate | Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days. | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Scarring |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ira A. Shivitz, M.D. | Cornea Consultants Of Nashville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea Consultants of Nashville | Nashville | Tennessee | 37203 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Zymaxid 0.5% Ophthalmic Solution | Drug | 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 | Drug | 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. |
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Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central.
| 29 days |
| 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 |
| 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 |
| Number of Participants With Treatment Failure | 29 days |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Number | participants |
| |||||||||||||||||||
| Gender | Number | participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Healing | The primary outcome will be complete healing of the corneal ulcer, defined as complete reepithelialization by Day 29. | Posted | Number | participant | 29 days |
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| Secondary | Healing Rate | Time to corneal ulcer reduction and/or total healing over a treatment course of 21 days. | Posted | Number | Days | 29 days |
| |||||||||||||||||||||||||||||||||||
| 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. | Data was not collected because there were no treatment failures in any of the treatment arms | Posted | 8 days |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Scarring | Scarring will be evaluated and measured in millimeters at Day 29 and classified as either peripheral or central. | Posted | Number | millimeters | 29 days |
| |||||||||||||||||||||||||||||||||||
| 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 | Posted | Number | units on a scale | Average of 6 times in a 29 day period |
| |||||||||||||||||||||||||||||||||||
| 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 | Posted | Number | units on a scale | Average of 6 times in a 29 day period |
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment Failure | Posted | Number | participants | 29 days |
|
29 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 0 | 0 | ||
| EG001 | 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. | 0 | 1 | 0 | 1 | ||
| EG002 | 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. | 0 | 1 | 0 | 1 |
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The study was terminated due to slow enrollment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ira Shivitz MD | Cornea Consultants of Nashville | 615-320-7200 | jhatley@corneaconsultants.net |
| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C522124 | besifloxacin |
| D000077734 | Gatifloxacin |
| D009883 | Ophthalmic Solutions |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| Title | Measurements |
|---|---|
|
| >=65 years |
|
| Male |
|
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. |
|
|
| OG002 | 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. |
|
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. |
|
|
| OG002 | 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. |
|
|
| OG002 |
| 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. |
|
|
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.
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