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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00293787
First received: February 17, 2006
Last updated: February 13, 2012
Last verified: February 2012

February 17, 2006
February 13, 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 ] [ Designated as safety issue: No ]
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00293787
C-04-03
Not Provided
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
February 2012

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