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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
 Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution
Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
Drug: Timolol 0.5% Ophthalmic Solution
Other: Timolol Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) Change at 3 Months from Baseline [ Time Frame: 3 months ]

Enrollment: 173
Study Start Date: July 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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
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
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00293800     History of Changes
Other Study ID Numbers: C-04-04
Study First Received: February 17, 2006
Last Updated: February 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Open-angle
glaucoma
ocular
hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
Travoprost
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 22, 2013