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

NCT00464438 | Completed Phase 4 Results

• 1 other identifier: 198782-003
• Study Type: interventional
• Target: 171
• Locations: 2 countries
• Sites: 2

Brief 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

Conditions

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of Patients With Microbiological Improvement

  Day 7

• Percentage of Patients With Improvement in Ocular Signs for Lid Erythema

  Days 7

• Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7

  Day 7

Study Arms (2)

1

EXPERIMENTAL

Drug: gatifloxacin

2

ACTIVE COMPARATOR

Drug: gatifloxacin; Drug: moxifloxacin 0.5% eye drops

Interventions

gatifloxacin DRUG

Day 1-6 = 1 drop of study medication three times a day

Also known as: Zymar®

1; 2

moxifloxacin 0.5% eye drops DRUG

Day 1-6 = 1 drop of study medication three times a day

Also known as: Vigamox®

2

Eligibility Criteria

• Age: Up to 31 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed with bacterial conjunctivitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

Whitby, Ontario, Canada

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

Gatifloxacin; Moxifloxacin; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan, Inc.

clinicaltrials@allergan.com

(714) 246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 23, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 21, 2011
• Results First Posted: September 21, 2011

Record last verified: 2011-08

Locations

CA (1); US (1)