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A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00509873
First received: July 30, 2007
Last updated: October 24, 2011
Last verified: October 2011

July 30, 2007
October 24, 2011
August 2007
June 2008   (final data collection date for primary outcome measure)
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).
Clearing of conjunctival hyperemia and conjunctival discharge on Day 6
Complete list of historical versions of study NCT00509873 on ClinicalTrials.gov Archive Site
  • Percentage of Patients With Microbiological Cure at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 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 Clinical Improvement of Ocular Signs at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.
  • Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6 [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
    Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis
Microbiological cure, clinical improvement of ocular signs, clinical improvement of ocular symptoms
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Not Provided

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Not Provided
Interventional
Phase 3
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 0.5% eye drops
    Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
  • Drug: placebo eye drops
    Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
  • Experimental: Gatifloxacin 0.5% Eye Drops
    Gatifloxacin 0.5% Eye Drops
    Intervention: Drug: Gatifloxacin 0.5% eye drops
  • Placebo Comparator: Placebo Eye Drops
    Placebo Eye Drops
    Intervention: Drug: placebo 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
578
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically diagnosed with bacterial conjunctivitis

Exclusion Criteria:

  • Signs and/or symptoms of conjunctivitis for more than 96 hours
  • Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
  • Clinical diagnosis of chlamydia in either eye
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00509873
198782-004
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
October 2011

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