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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:
NCT00293800
First received: February 17, 2006
Last updated: February 11, 2012
Last verified: February 2012

February 17, 2006
February 11, 2012
July 2004
December 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 NCT00293800 on ClinicalTrials.gov Archive Site
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A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension
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The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in 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
  • 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 0.5% Ophthalmic Solution
    Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension
  • Other: Timolol Vehicle
    Placebo
  • Experimental: Travoprost/Timolol
    One drop Travoprost 0.004%/Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Timolol vehicle in the study eye(s) 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%
    One drop Timolol 0.5% in the study eye(s) each morning at 8 a.m. and one drop Xalatan in the study eye(s) each evening at 8 p.m. for 3 months
    Interventions:
    • Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
    • Drug: Timolol 0.5% Ophthalmic Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
December 2005
December 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 intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant
  • History of chronic or recurrent severe inflammatory eye disease.
  • History of ocular infection or ocular inflammation within the past three 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
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NCT00293800
C-04-04
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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