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A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00464438
First received: April 19, 2007
Last updated: August 17, 2011
Last verified: August 2011
History of Changes

April 19, 2007
August 17, 2011
June 2007
September 2008   (final data collection date for primary outcome measure)
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
clearing of conjunctival erythema and conjunctival discharge at day 7
Complete list of historical versions of study NCT00464438 on ClinicalTrials.gov Archive Site
  • Percentage of Patients With Microbiological Improvement [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture).
  • Percentage of Patients With Improvement in Ocular Signs for Lid Erythema [ Time Frame: Days 7 ] [ Designated as safety issue: No ]
    Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
  • Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

    Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate,

    +3=severe).
microbiological improvement, improvement in ocular signs
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis
Not Provided

This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bacterial Conjunctivitis
  • Drug: gatifloxacin
    Day 1-6 = 1 drop of study medication three times a day
    Other Name: Zymar®
  • Drug: moxifloxacin 0.5% eye drops
    Day 1-6 = 1 drop of study medication three times a day
    Other Name: Vigamox®
  • Experimental: 1
    Intervention: Drug: gatifloxacin
  • Active Comparator: 2
    Interventions:
    • Drug: gatifloxacin
    • Drug: moxifloxacin 0.5% eye drops
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosed with bacterial conjunctivitis

Exclusion Criteria:

  • chemical or foreign body trauma to either eye
  • infection in either eye (besides bacterial conjunctivitis)
  • white spots in the cornea or ulcers in either eye
  • clinical diagnosis of chlamydia or gonorrhea in either eye
Both
up to 31 Days
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00464438
198782-003
Not Provided
Therapeutic Area Head, Allergan, Inc.
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
August 2011

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