Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

30. mars 2010 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Texas
      • Fort Worth, Texas, Forente stater, 76134
        • Contact Alcon Call Center for Trial Locations

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. 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
  2. Must experience some matting in the affected eye(s).
  3. 1 year of age or older, of any race and either sex
  4. 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.
  5. 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:

  1. Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for > 24 hours.
  2. Any current lid disease on clinical examination.
  3. Known or suspected allergy or hypersensitivity to fluoroquinolones.
  4. Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
  5. 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).
  6. Use of topical ocular medications during the study period.
  7. 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.
  8. Women of childbearing potential not using reliable means of birth control.
  9. Women who are pregnant or lactating.
  10. Enrollment of more than one person per household at the same time.
  11. 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.
  12. Participation in any investigational drug or device study within 30 days of entering this study.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2008

Primær fullføring (Faktiske)

1. februar 2009

Studiet fullført (Faktiske)

1. februar 2009

Datoer for studieregistrering

Først innsendt

25. november 2008

Først innsendt som oppfylte QC-kriteriene

25. november 2008

Først lagt ut (Anslag)

26. november 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. mars 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mars 2010

Sist bekreftet

1. mars 2010

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere