Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment
30. marts 2010 opdateret af: Alcon Research
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
24
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Fort Worth, Texas, Forenede Stater, 76134
- Contact Alcon Call Center for Trial Locations
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Vigamox
Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)
|
Moxifloxacin 5mg/mL 3 times daily for 7 days
|
|
Placebo komparator: BSS Placebo
Balanced Salt Solution
|
Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exploratory Outcomes From Digital Photography
Tidsramme: 24 hours after administration of first dose
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exploratory Evaluation of Changes in Ocular Signs and Symptoms
Tidsramme: Baseline (Day 1) to Day 2
|
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
|
|
Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans
Tidsramme: 24 hours after administration of first dose
|
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
Tidsramme: 24 hour after administration of first dose
|
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
Tidsramme: 24 hours after administration of first dose
|
Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
|
24 hours after administration of first dose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2008
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. februar 2009
Datoer for studieregistrering
Først indsendt
25. november 2008
Først indsendt, der opfyldte QC-kriterier
25. november 2008
Først opslået (Skøn)
26. november 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. marts 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. marts 2010
Sidst verificeret
1. marts 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SMA-08-03
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .