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

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ClinicalTrials.gov Identifier: NCT01238783
Recruitment Status : Withdrawn
First Posted : November 11, 2010
Last Update Posted : December 1, 2011
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension Drug: AL-15469A 0.5% Drug: AL-6515 0.3% Drug: Vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2011
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
Topical ocular dosed 3 times per day for 3 days
Experimental: AL-15469A 0.5% Drug: AL-15469A 0.5%
Topical ocular dosed 3 times per day for 3 days
Experimental: AL-6515 0.3% Drug: AL-6515 0.3%
Topical ocular dosed 3 times per day for 3 days
Placebo Comparator: Vehicle Drug: Vehicle
Topical ocular dosed 3 times per day for 3 days



Primary Outcome Measures :
  1. Sustained Clinical Cure rate [ Time Frame: Day 3 ]
  2. End of therapy Clinical Cure rate [ Time Frame: Day 4 ]

Secondary Outcome Measures :
  1. Sustained bulbar conjunctival injection [ Time Frame: Day 3 ]
  2. Microbiological Success [ Time Frame: Day 4 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01238783     History of Changes
Other Study ID Numbers: C-09-061
First Posted: November 11, 2010    Key Record Dates
Last Update Posted: December 1, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection