- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00798577
Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 4
Kontakty a umístění
Studijní místa
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Texas
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Fort Worth, Texas, Spojené státy, 76134
- Contact Alcon Call Center for Trial Locations
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Diagnosis in one or both eyes of bacterial conjunctivitis based on:
- symptoms less than or equal to 24 hours prior to first visit
- rating > or equal to 1 for bulbar conjunctival injection
- must have a rating > 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at Visit 1, and
- 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:
- Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for > 24 hours.
- Any current lid disease on clinical examination.
- Known or suspected allergy or hypersensitivity to fluoroquinolones.
- Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
- Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency).
- Use of topical ocular medications during the study period.
- Antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study.
- Women of childbearing potential not using reliable means of birth control.
- Women who are pregnant or lactating.
- Enrollment of more than one person per household at the same time.
- Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
- Participation in any investigational drug or device study within 30 days of entering this study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Vigamox
Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)
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Moxifloxacin 5mg/mL 3 times daily for 7 days
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Komparátor placeba: BSS Placebo
Balanced Salt Solution
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Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Exploratory Outcomes From Digital Photography
Časové okno: 24 hours after administration of first dose
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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.
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24 hours after administration of first dose
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Exploratory Evaluation of Changes in Ocular Signs and Symptoms
Časové okno: Baseline (Day 1) to Day 2
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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. |
Baseline (Day 1) to Day 2
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Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
Časové okno: 24 hours after administration of first dose
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Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
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24 hours after administration of first dose
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Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like
Časové okno: 24 hour after administration of first dose
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Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
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24 hour after administration of first dose
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Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae
Časové okno: 24 hours after administration of first dose
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Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
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24 hours after administration of first dose
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SMA-08-03
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