Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

This study has been completed.
Sponsor:
Collaborator:
Topical Solutions Ltd.
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00798577
First received: November 25, 2008
Last updated: March 30, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Bacterial Conjunctivitis
Drug: Vigamox Ophthalmic Solution
Drug: BSS placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Exploratory Outcomes From Digital Photography [ Time Frame: 24 hours after administration of first dose ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Exploratory Evaluation of Changes in Ocular Signs and Symptoms [ Time Frame: Baseline (Day 1) to Day 2 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Eradication percent (absence of specified bacteria) of each bacteria identified at Day 1


Enrollment: 24
Study Start Date: October 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vigamox
Vigamox Ophthalmic Solution (Moxifloxacin 5mg/mL)
Drug: Vigamox Ophthalmic Solution
Moxifloxacin 5mg/mL 3 times daily for 7 days
Placebo Comparator: BSS Placebo
Balanced Salt Solution
Drug: BSS placebo
Balanced Saline Solution for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798577

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Topical Solutions Ltd.
  More Information

No publications provided

Responsible Party: Paul Cockrum, PhD, Director - Medical Affairs, Alcon Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00798577     History of Changes
Other Study ID Numbers: SMA-08-03
Study First Received: November 25, 2008
Results First Received: March 2, 2010
Last Updated: March 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Bacterial Conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014