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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
  Purpose

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


Condition Intervention Phase
Bacterial Conjunctivitis
 Drug: gatifloxacin
Drug: moxifloxacin 0.5% eye drops
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).



Enrollment: 171
Study Start Date: June 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: gatifloxacin
Day 1-6 = 1 drop of study medication three times a day
Other Name: Zymar®
Active Comparator: 2 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®

  Eligibility

Ages Eligible for Study:   up to 31 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464438

Locations
United States, California
Sacramento, California, United States
Canada, Ontario
Whitby, Ontario, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00464438     History of Changes
Other Study ID Numbers: 198782-003
Study First Received: April 19, 2007
Results First Received: June 15, 2010
Last Updated: August 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Gatifloxacin
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 May 19, 2013