AL-15469A for the Treatment of Bacterial Conjunctivitis

Alcon

Status and phase: Completed; Phase 3

Conditions: Bacterial Conjunctivitis

Treatments: Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base; Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00332293

C-04-40

Details and patient eligibility

About

The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.

Enrollment: 695 patients

Sex: All

Ages: 1+ month old

Volunteers: No Healthy Volunteers

Inclusion criteria

• signs and symptoms of bacterial conjunctivitis
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• under 1 mo. age
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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695 participants in 2 patient groups

Moxifloxacin

Experimental group

Treatment:

Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%

VIGAMOX

Active Comparator group

Treatment:

Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base