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Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

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: NCT00465621
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : July 29, 2008
Sponsor:
Information provided by:
Alcon Research

Tracking Information
First Submitted Date  ICMJE April 23, 2007
First Posted Date  ICMJE April 25, 2007
Last Update Posted Date July 29, 2008
Study Start Date  ICMJE March 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2007)		 Mean IP Change from Baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Brief Summary The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807 Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in patients with open-angle glaucoma or ocular hypertension
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Open-Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE Drug: Xalatan
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: April 23, 2007)		 150
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Open-angle glaucoma
  • ocular hypertension

Exclusion Criteria:

- VA worse than 0.60
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 NCT00465621
Other Study ID Numbers  ICMJE C-06-10
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: Theresa Landry Alcon Research
PRS Account Alcon Research
Verification Date July 2008

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