Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Safety and Efficacy of Travoprost/Timolol BAC-free

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: September 24, 2008
Last updated: July 14, 2014
Last verified: July 2014

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. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).

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
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 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) combined across all visits and timepoints [ Time Frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM) ] [ Designated as safety issue: No ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).

Secondary Outcome Measures:
  • Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit [ Time Frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM) ] [ Designated as safety issue: No ]
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).

Enrollment: 87
Study Start Date: June 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
Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks
Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution
Active Comparator: Travoprost/Timolol
Travoprost 0.004%/Timolol 0.5% ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks
Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution
Other Name: DuoTrav®


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

Inclusion Criteria:

  • Open-angle glaucoma or confirmed ocular hypertension.
  • 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.
  • Sign an informed consent form.
  • Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
  • Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
  • History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
  • History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
  • Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
  • Severe central visual field loss in either eye.
  • Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
  • History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
  • History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
  • 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.

Please refer to this study by its identifier: NCT00760539

Manabe Clinic
Hamura, Tokyo, Japan, 205-0001
Sponsors and Collaborators
Alcon Research
Study Director: Pamela Smith, B.S. Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research Identifier: NCT00760539     History of Changes
Other Study ID Numbers: C-08-08
Study First Received: September 24, 2008
Last Updated: July 14, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on February 27, 2015