Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

Alcon

Status and phase: Completed; Phase 3

Conditions: Bacterial Conjunctivitis

Treatments: Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%; Other: Moxifloxacin AF Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759148

C-07-40

Details and patient eligibility

About

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.

Enrollment: 1,179 patients

Sex: All

Ages: 1+ month old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,179 participants in 2 patient groups, including a placebo group

Moxifloxacin AF

Experimental group

Description:

Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days

Treatment:

Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%

Vehicle

Placebo Comparator group

Description:

Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days

Treatment:

Other: Moxifloxacin AF Vehicle