Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis

Alcon

Status and phase: Withdrawn; Phase 2

Conditions: Bacterial Conjunctivitis

Treatments: Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension; Drug: AL-6515 0.3%; Drug: AL-15469A 0.5%; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238783

C-09-061

Details and patient eligibility

About

To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients of any race
• 5 years of age and older at the time of the Day 1 visit
• with a primary clinical diagnosis of bacterial conjunctivitis.

Exclusion criteria

• Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
• Presence of punctal plug or punctal occlusion
• Visual Acuity worse than 20/80
• Upper respiratory infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 4 patient groups, including a placebo group

AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension

Experimental group

Treatment:

Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension

AL-15469A 0.5%

Experimental group

Treatment:

Drug: AL-15469A 0.5%

AL-6515 0.3%

Experimental group

Treatment:

Drug: AL-6515 0.3%

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle