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
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
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
Travoprost
Maleic acid
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
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014