Safety and Efficacy of Travoprost/Timolol BAC-free

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00760539
First received: September 24, 2008
Last updated: July 19, 2012
Last verified: April 2012
  Purpose

The primary objective of this study is to compare the safety and IOP-lowering efficacy of Travoprost/Timolol BAC-free to Travoprost/Timolol in patients with primary open-angle glaucoma or ocular hypertension as a global study which is conducted in the US (C-07-64) and Japan (C-08-08).


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, Investigator)
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:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) [ Time Frame: 9AM, 11AM, 4PM at Week 2 and Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients with IOP < 18 mmHg or IOP percent reduction ≥ 30% [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: August 2008
Study Completion Date: December 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
1 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®)
1 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:

  • Patients 20 years of age or older of either sex or race diagnosed with primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • History or current evidence of chronic or recurrent severe inflammatory eye disease, progressive retinal disease, unstable/uncontrolled cardiovascular, hepatic or renal disease, bronchial asthma, or severe chronic obstructive pulmonary disease.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760539

Locations
Japan
Manabe Clinic
Hamura, Tokyo, Japan, 205-0001
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00760539     History of Changes
Other Study ID Numbers: C-08-08
Study First Received: September 24, 2008
Last Updated: July 19, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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 April 16, 2014