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

Bacterial Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464438
• Other study ID #: 198782-003
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2007
• Last updated: August 17, 2011
• Start date: June 2007
• Est. completion date: September 2008

Study information

• Verified date: August 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 31 Days

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bacterial Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

Drug:
• gatifloxacin
Day 1-6 = 1 drop of study medication three times a day
• moxifloxacin 0.5% eye drops
Day 1-6 = 1 drop of study medication three times a day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7	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).	Day 7	No
Secondary	Percentage of Patients With Microbiological Improvement	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).	Day 7	No
Secondary	Percentage of Patients With Improvement in Ocular Signs for Lid Erythema	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).	Days 7	No
Secondary	Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7	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).	Day 7	No