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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01238783
First received: November 9, 2010
Last updated: November 29, 2011
Last verified: November 2011
November 9, 2010
November 29, 2011
January 2011
December 2011   (Final data collection date for primary outcome measure)
  • Sustained Clinical Cure rate [ Time Frame: Day 3 ]
  • End of therapy Clinical Cure rate [ Time Frame: Day 4 ]
Same as current
Complete list of historical versions of study NCT01238783 on ClinicalTrials.gov Archive Site
  • Sustained bulbar conjunctival injection [ Time Frame: Day 3 ]
  • Microbiological Success [ Time Frame: Day 4 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis
Not Provided
To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Bacterial Conjunctivitis
  • Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
    Topical ocular dosed 3 times per day for 3 days
  • Drug: AL-15469A 0.5%
    Topical ocular dosed 3 times per day for 3 days
  • Drug: AL-6515 0.3%
    Topical ocular dosed 3 times per day for 3 days
  • Drug: Vehicle
    Topical ocular dosed 3 times per day for 3 days
  • Experimental: AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension
    Intervention: Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension
  • Experimental: AL-15469A 0.5%
    Intervention: Drug: AL-15469A 0.5%
  • Experimental: AL-6515 0.3%
    Intervention: Drug: AL-6515 0.3%
  • Placebo Comparator: Vehicle
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01238783
C-09-061
No
Not Provided
Not Provided
Not Provided
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP