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The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Experimental | Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 |
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| Ofloxacin | Active Comparator | Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin ophthalmic solution, 0.5% | Drug |
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| Ofloxacin ophthalmic solution, 0.3% |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure Rate | Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit. | Day 9 |
| Microbiological Success Rate | Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit. | Day 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Yu, Lead CSM | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon (China) Ophthalmic Product Co., Ltd. | Beijing | China |
Of the 985 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (982).
Participants were recruited from 16 study centers located in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin | 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 |
| FG001 | Ofloxacin | 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| COMPLETED |
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| NOT COMPLETED |
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This analysis population includes all participants who were administered study medication or potentially used study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxifloxacin | 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 |
| BG001 | Ofloxacin | 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | 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 | Clinical Cure Rate | Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit. | This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data. | Posted | Number | percentage of participants | Day 9 |
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| Primary | Microbiological Success Rate | Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit. | This analysis population includes all patients who received study medication, had no major protocol deviations, had bacteria present at Day 1 visit, and had baseline and TOC/exit data or early exit data. | Posted | Number | percentage of participants | Day 9 |
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Adverse events (AEs) were collected for the duration of the study (May 2012 to April 2014). This analysis group includes all patients who were administered or potentially used study medication.
An adverse event was defined as any untoward medical occurrence in a patient who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment.
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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 | 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 | 1 | 489 | 0 | 489 | ||
| EG001 | Ofloxacin | 1 drop instilled TID in each eye for 7 days with a TOC at Day 9 | 0 | 493 | 0 | 493 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Firoz Vohra, Project Head, Pharma | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| 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 |
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| Male |
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