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

Allergan

Status and phase: Completed; Phase 4

Conditions: Bacterial Conjunctivitis

Treatments: Drug: gatifloxacin; Drug: moxifloxacin 0.5% eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT00464438

198782-003

Details and patient eligibility

About

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

Enrollment: 171 patients

Sex: All

Ages: Under 31 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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171 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: gatifloxacin

2

Active Comparator group

Treatment:

Drug: moxifloxacin 0.5% eye drops

Drug: gatifloxacin