A 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00311389
First received: April 4, 2006
Last updated: February 11, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to evaluate the intraocular pressure(IOP)-lowering efficacy of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Glaucoma, Open-angle
Ocular Hypertension
Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution
Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution
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 12-Month Study to Evaluate the Efficacy and Safety of Once-Daily Instillation of Combination Glaucoma Therapy in Patients With 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) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 408
Study Start Date: January 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travoprost/Timolol
1 drop in the affected eye(s) once daily in the morning for 12 months
Drug: Travoprost 0.004%/Timolol maleate 0.5% ophthalmic solution
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Active Comparator: Latanoprost/Timolol
1 drop in the affected eye(s) once daily in the morning for 12 months
Drug: Latanoprost 0.005%/Timolol 0.005% ophthalmic solution
Commercially marketed ophthalmic solution intended 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:

- As specified in protocol

Exclusion Criteria:

- As specified in protocol

  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311389

Locations
Belgium
European Facilitiies
Puurs, Belgium
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00311389     History of Changes
Other Study ID Numbers: C-02-28
Study First Received: April 4, 2006
Last Updated: February 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma
POAG
OAG
OHT

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

ClinicalTrials.gov processed this record on October 23, 2014