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The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin AF | Experimental | Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days |
|
| Vehicle | Placebo Comparator | Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5% | Drug | Eye drops |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure at the Day 4 (EOT)/Exit Visit | Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis. | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological Success at the Day 4 (EOT)/Exit Visit | Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis. | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Research, Ltd. | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21681652 | Derived | Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14. |
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1179 subjects with bacterial conjunctivitis were randomized and treated to Moxifloxacin AF or Moxifloxacin AF vehicle.
Subjects were recruited from 108 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin AF | Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days |
| FG001 | Vehicle | Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This population analysis includes all subjects who received study drug (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxifloxacin AF | Moxifloxacin AF Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days |
| BG001 | Vehicle | Moxifloxacin AF Vehicle, 1 drop in each eye twice daily for 3 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Clinical Cure at the Day 4 (EOT)/Exit Visit | Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis. | This analysis population includes all patients who received drug, had at least 1 on-therapy visit and were pathogen positive for bacteria on Day 1 (Microbiological Intent-to-Treat (MBITT) Analysis Set). | Posted | Number | percentage of subjects | Day 4 |
|
Baseline through study completion, an average of 4 days
An AE was defined as any untoward change (expected or unexpected) in a patient's ophthalmic and/or medical health that occurred after initiation of study treatment. AEs were obtained as solicited comments from the study patient/guardian and as observations by the study investigator.
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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 | Moxifloxacin AF | Subjects exposed to Moxifloxacin AF | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Moxifloxacin AF Vehicle |
| Other |
Inactive ingredients used as a placebo for masking purposes |
|
| Lost to Follow-up |
|
| Treatment Failure |
|
| Reason not given |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Vehicle |
Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days |
|
|
| Secondary | Microbiological Success at the Day 4 (EOT)/Exit Visit | Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis. | MBITT Analysis Set | Posted | Number | percentage of subjects | Day 4 |
|
|
|
| 593 |
| 0 |
| 593 |
| 0 |
| 593 |
| EG001 | Vehicle | Subjects exposed to Moxifloxacin AF Vehicle | 0 | 586 | 0 | 586 | 0 | 586 |
Sponsor reserves the right to review study related information prior to presentation or publication.
| D015817 | Eye Infections |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |