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
  Purpose

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.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
Drug: Travoprost 0.004% / Timolol 0.5% Ophthalmic Solution
Other: Timolol Vehicle
Drug: Latanoprost 0.005% Ophthalmic Solution (XALATAN)
Drug: Timolol Maleate Ophthalmic Solution 0.5%
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
Official Title: A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: June 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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%
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
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

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00293787     History of Changes
Other Study ID Numbers: C-04-03
Study First Received: February 17, 2006
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014