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

Allergan

Status and phase: Completed; Phase 3

Conditions: Bacterial Conjunctivitis

Treatments: Drug: Gatifloxacin 0.5% eye drops; Drug: placebo eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT00509873

198782-004

Details and patient eligibility

About

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

Enrollment: 578 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

578 participants in 2 patient groups, including a placebo group

Gatifloxacin 0.5% Eye Drops

Experimental group

Description:

Gatifloxacin 0.5% Eye Drops

Treatment:

Drug: Gatifloxacin 0.5% eye drops

Placebo Eye Drops

Placebo Comparator group

Description:

Placebo Eye Drops

Treatment:

Drug: placebo eye drops