Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Diagnosed with bacterial conjunctivitis in 1 or both eyes;

• Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative;

• Agrees to comply with the visit schedule and other requirements of the study;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1;

• Presence of concomitant viral infection;

• Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin;

• Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery;

• Infants undergoing treatment for retinopathy of prematurity;

• Contact lens wear during the course of the study;

• Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better;

• Use of medications, as specified in the protocol;

• Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study;

• Known or suspected allergy or hypersensitivity to fluoroquinolones;

• Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy;

• Other protocol-specified exclusion criteria may apply.