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AL-15469A for the Treatment of Bacterial Conjunctivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00332293
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE May 31, 2006
First Posted Date  ICMJE June 1, 2006
Last Update Posted Date November 18, 2016
Study Start Date  ICMJE May 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2006)
Clinical cure and microbiological success
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2006)
Individual signs and symptoms of bacterial conjunctivitis at each visit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AL-15469A for the Treatment of Bacterial Conjunctivitis
Official Title  ICMJE An Evaluation of the Safety and Efficacy of Moxifloxacin AF Ophthalmic Solution 0.5% for the Treatment of Bacterial Conjunctivitis in India
Brief Summary The purpose of the study is to determine whether AL-15469A is safe and effective in the treatment of bacterial conjunctivitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bacterial Conjunctivitis
Intervention  ICMJE
  • Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%
    1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
  • Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base
    1 drop into the conjunctival sac of both eyes 3 times a day for 3 days
    Other Name: VIGAMOX
Study Arms  ICMJE
  • Experimental: Moxifloxacin
    Intervention: Drug: Moxifloxacin Alternative Formulation Ophthalmic Solution 0.5%
  • Active Comparator: VIGAMOX
    Intervention: Drug: Moxifloxacin hydrochloride ophthalmic solution 0.5% as base
Publications * Tauber S, Cupp G, Garber R, Bartell J, Vohra F, Stroman D. Microbiological efficacy of a new ophthalmic formulation of moxifloxacin dosed twice-daily for bacterial conjunctivitis. Adv Ther. 2011 Jul;28(7):566-74. doi: 10.1007/s12325-011-0037-x. Epub 2011 Jun 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2012)
695
Original Enrollment  ICMJE
 (submitted: May 31, 2006)
675
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00332293
Other Study ID Numbers  ICMJE C-04-40
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date March 2012

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