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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: NCT00331916
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : September 29, 2009
Sponsor:
Information provided by:
Alcon Research

Tracking Information
First Submitted Date  ICMJE May 30, 2006
First Posted Date  ICMJE May 31, 2006
Last Update Posted Date September 29, 2009
Study Start Date  ICMJE November 2005
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2006)
Clinical cure and microbiological success
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 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 AL-15469A for the Treatment of Bacterial Conjunctivitis
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
Primary Purpose: Treatment
Condition  ICMJE Bacterial Conjunctivitis
Intervention  ICMJE Drug: quinolone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: May 30, 2006)
600
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signs & Symptoms of conjunctivitis

Exclusion Criteria:

  • Under 1 mo. age
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 NCT00331916
Other Study ID Numbers  ICMJE C-04-38
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stella Robertson, Ph.D. Study Director
PRS Account Alcon Research
Verification Date September 2009

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