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

NCT ID: NCT01238783

Last Updated: 2011-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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

Detailed Description

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Conditions

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Bacterial Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Topical ocular dosed 3 times per day for 3 days

AL-15469A 0.5%

Group Type EXPERIMENTAL

AL-15469A 0.5%

Intervention Type DRUG

Topical ocular dosed 3 times per day for 3 days

AL-6515 0.3%

Group Type EXPERIMENTAL

AL-6515 0.3%

Intervention Type DRUG

Topical ocular dosed 3 times per day for 3 days

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical ocular dosed 3 times per day for 3 days

Interventions

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

Topical ocular dosed 3 times per day for 3 days

Intervention Type DRUG

AL-15469A 0.5%

Topical ocular dosed 3 times per day for 3 days

Intervention Type DRUG

AL-6515 0.3%

Topical ocular dosed 3 times per day for 3 days

Intervention Type DRUG

Vehicle

Topical ocular dosed 3 times per day for 3 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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C-09-061

Identifier Type: -

Identifier Source: org_study_id