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A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293787
First Posted: February 20, 2006
Last Update Posted: February 14, 2012
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.
Information provided by (Responsible Party):
Alcon Research
February 17, 2006
February 20, 2006
February 14, 2012
June 2004
August 2005   (Final data collection date for primary outcome measure)
Mean intraocular pressure (IOP) change at 3 months from baseline [ Time Frame: 3 months ]
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Complete list of historical versions of study NCT00293787 on ClinicalTrials.gov Archive Site
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A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
The purpose of the study is to evaluate the safety and effectiveness of an investigational therapy for treating patients with open-angle glaucoma or ocular hypertension.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Open-angle Glaucoma
  • Ocular Hypertension
  • Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution
    Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
  • Other: Timolol Vehicle
    Placebo
  • Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
    Commercially marketed ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
    Other Name: XALATAN
  • Drug: Timolol Maleate Ophthalmic Solution 0.5%
    Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
  • Experimental: Travoprost 0.004%/Timolol 0.5%
    Travoprost 0.004%/Timolol 0.5% in both eyes each morning at 8 a.m. and Timolol vehicle in both eyes each evening at 8 p.m. for 3 months
    Interventions:
    • Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution
    • Other: Timolol Vehicle
  • Active Comparator: Xalatan + Timolol 0.5%
    Timolol 0.5% in both eyes each morning at 8 a.m. and Xalatan in both eyes each evening at 8 p.m. for 3 months
    Interventions:
    • Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
    • Drug: Timolol Maleate Ophthalmic Solution 0.5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
August 2005
August 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years or older.
  • Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
  • Mean IOP in each eye less than 18 mmHg at the screening visit.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant.
  • History of chronic or recurrent severe inflammatory eye disease.
  • Ocular trauma within the past six months in either eye.
  • Other protocol-defined exclusion criteria may apply.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00293787
C-04-03
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Alcon Research
Alcon Research
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Not Provided
Alcon Research
February 2012

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