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Trial record 14 of 24 for:    "Bacterial Infectious Disease" | "Polyestradiol phosphate" | ( Map: United States )

Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

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ClinicalTrials.gov Identifier: NCT00798577
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : March 31, 2010
Last Update Posted : March 31, 2010
Sponsor:
Collaborator:
Topical Solutions Ltd.
Information provided by:
Alcon Research

Tracking Information
First Submitted Date  ICMJE November 25, 2008
First Posted Date  ICMJE November 26, 2008
Results First Submitted Date  ICMJE March 2, 2010
Results First Posted Date  ICMJE March 31, 2010
Last Update Posted Date March 31, 2010
Study Start Date  ICMJE October 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Exploratory Outcomes From Digital Photography [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Change from baseline of bacterial conjunctivitis signs and symptoms [ Time Frame: 24 hours from diagnosis (Visit 1) ]
Change History Complete list of historical versions of study NCT00798577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • Exploratory Evaluation of Changes in Ocular Signs and Symptoms [ Time Frame: 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.
  • Microbiological Culture Evaluation/Eradication Percent - Enterobacter Faecalis and Candida Albicans [ Time Frame: 24 hours after administration of first dose ]
    Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
  • Microbiological Culture Evaluation/Eradication Percent - Eradication of All Other Isolates and Corynform-like [ Time Frame: 24 hour after administration of first dose ]
    Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
  • Microbiological Culture Evaluation/Eradication Percent - Staphylococcus Aureus, Steptococcus Pneumoniae, and Enterobacter Cloacae [ Time Frame: 24 hours after administration of first dose ]
    Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
Change from baseline in microbiological specimen collection [ Time Frame: 24 hours from diagnosis (Visit 1) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Conjunctivitis
Intervention  ICMJE
  • Drug: Vigamox Ophthalmic Solution
    Moxifloxacin 5mg/mL 3 times daily for 7 days
  • Drug: BSS placebo
    Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
Study Arms  ICMJE
  • Experimental: Vigamox
    Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)
    Intervention: Drug: Vigamox Ophthalmic Solution
  • Placebo Comparator: BSS Placebo
    Balanced Salt Solution
    Intervention: Drug: BSS placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2008)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798577
Other Study ID Numbers  ICMJE SMA-08-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Cockrum, PhD, Director - Medical Affairs, Alcon Laboratories, Inc.
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Topical Solutions Ltd.
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP