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| Name | Class |
|---|---|
| Topical Solutions Ltd. | INDUSTRY |
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The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vigamox | Experimental | Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL) |
|
| BSS Placebo | Placebo Comparator | Balanced Salt Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigamox Ophthalmic Solution | Drug | Moxifloxacin 5mg/mL 3 times daily for 7 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcomes From Digital Photography | Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment. | 24 hours after administration of first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Evaluation of Changes in Ocular Signs and Symptoms | Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis: Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale. |
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Inclusion Criteria:
Diagnosis in one or both eyes of bacterial conjunctivitis based on:
Must experience some matting in the affected eye(s).
1 year of age or older, of any race and either sex
Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation.
Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vigamox | Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days |
| FG001 | Placebo | Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vigamox | Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days |
| BG001 | Placebo | Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Exploratory Outcomes From Digital Photography | Photographs were taken before and after treatment. Outcome is the number of patients whose photographs showed a subjective visual change based upon an exploratory review of patient photographs in signs of bacterial conjunctivitis before and after treatment. | Posted | Number | Participants | 24 hours after administration of first dose |
|
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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 | Vigamox | Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Labs | 1.888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| BSS placebo |
| Drug |
Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days |
|
| Baseline (Day 1) to Day 2 |
| Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 | 24 hours after administration of first dose |
| Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 | 24 hour after administration of first dose |
| Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 | 24 hours after administration of first dose |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Exploratory Evaluation of Changes in Ocular Signs and Symptoms | Number of patients who had clinical resolution (0 on all scales below) from baseline (Day 1) to Day 2 in ocular and symptoms of bacterial conjunctivitis: Bulbar Conjunctival Injection - 0 (none) to 4 (Severe) scale. Conjunctival Discharge (Mucopurulent) - 0 (none) to 3 (Severe) scale. Lid Erythema - 0 (none) to 3 (Severe) scale. Lid Swelling - 0 (none) to 3 (Severe) scale. Palpebral Conjunctiva - 0 (none) to 3 (Severe) scale. Foreign Body Sensation - 0 (none) to 3 (Severe) scale. Tearing - 0 (none) to 3 (Severe) scale. Photophobia - 0 (none) to 3 (Severe) scale. | Posted | Number | Participants | Baseline (Day 1) to Day 2 |
|
|
|
| Secondary | Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 | Posted | Number | Percent bacteria eradicated | 24 hours after administration of first dose |
|
|
|
| Secondary | Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 | No patients in the Placebo group had Corynform-like bacteria (or other types of bacteria) identified at Day 1 | Posted | Number | Percent bacteria eradicated | 24 hour after administration of first dose |
|
|
|
| Secondary | Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae | Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1 | No patients in the Vigamox group had Staphylococcus aureus, Steptococcus pneumoniae, or Enterobacter cloacae identified at Day 1. | Posted | Number | Percent bacteria eradicated | 24 hours after administration of first dose |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Placebo | Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days | 0 | 7 | 0 | 7 |
All presentations/publications of study results are subject to Alcon approval.
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| Title | Measurements |
|---|---|
|