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A Phase III Study of Travoprost/Timolol Combination 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:
NCT00672997
First received: May 2, 2008
Last updated: April 3, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
 Drug: Travoprost 0.004%/Timolol 0.5% BAC-free Ophthalmic Solution
Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (DuoTrav®)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Six-Week, Multi-Center, Double-Masked, Safety and Efficacy Study of Travoprost 0.004%/Timolol 0.5% BAC-free Compared to Travoprost 0.004%/Timolol 0.5% in Patients With Open-Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) [ Time Frame: 9 AM, 11 AM, 4 PM at Week 2 and Week 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: Yes ]

Enrollment: 264
Study Start Date: May 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travoprost /Timolol BAC-free
One drop in each eye, once daily (QD) at 9 AM, for six weeks
 Drug: Travoprost 0.004%/Timolol 0.5% BAC-free Ophthalmic Solution
One drop in each eye, once daily (QD) at 9 AM (±30 minutes) for six (6) weeks
Active Comparator: Travoprost/Timolol
One drop in each eye, once daily (QD) at 9 AM, for six weeks
 Drug: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (DuoTrav®)
One drop in each eye, once daily (QD) at 9 AM (±30 minutes) for six (6) weeks
Other Name: DuoTrav®

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 & 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 & 2.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Age related.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672997

Locations
United States, Texas
El Paso
El Paso, Texas, United States, 79902
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00672997     History of Changes
Other Study ID Numbers: C-07-64
Study First Received: May 2, 2008
Last Updated: April 3, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Glaucoma
Hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
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 19, 2013