Travoprost 0.004%/Timolol 0.5% Versus Latanoprost 0.005%/Timolol in Chinese Patients With Open-Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872651
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : March 28, 2013
Information provided by (Responsible Party):
Alcon Research

Brief Summary:

Eligible patients will be randomized in a 1.1 ratio to receive Travoprost 0.004%/timolol 0.5% once daily or Latanoprost 0.005%/Timolol 0.5% once a day for 8 Weeks. The study treatments will be compared for mean diurnal intraocular pressure (IOP) change from baseline at Week 8.

Safety parameters measured at 4 study visits: ocular signs, visual acuity, dilated fundus, cardiovascular parameters (blood pressure and pulse), and adverse events.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: Travoprost 0.004%/Timolol 0.5% Drug: Latanoprost 0.005% / Timolol 0.5% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: Travoprost 0.004%/Timolol 0.5%
Travoprost 0.004%/Timolol 0.5%
Drug: Travoprost 0.004%/Timolol 0.5%
Travoprost 0.004%/Timolol 0.5%

Active Comparator: Latanoprost 0.005% / Timolol 0.5%
Latanoprost 0.005% / Timolol 0.5%
Drug: Latanoprost 0.005% / Timolol 0.5%
Latanoprost 0.005% / Timolol 0.5%

Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 8 weeks ]
    Mean Diurnal Intraocular Pressure (IOP) (averaged at 9 AM, 11 AM and 4 PM) change from baseline at Week 8.

Secondary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: 8 weeks ]
    Mean IOP change from baseline at 9 AM at Week 2 and Week 6 visits and at 9 AM, 11 AM and 4 PM at Week 8 visit.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients of either sex and any race, 18 years of age or older, diagnosed with open angle glaucoma or ocular hypertension who are not sufficiently responsive to topical beta-blockers or prostaglandin analogues.
  • Patients must meet the following IOP criteria in at least one eye. For each qualifying eye, the mean IOP should be ≥21 mmHg at 9 AM and 11 AM time points at the eligibility visit
  • The mean IOP in either eye at the eligibility visit must not be greater than 35 mmHg at any time point.

Exclusion Criteria:

  • Patients with any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension.
  • Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) angle in either eye, as measured by gonioscopy
  • Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
  • Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of ≤ 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
  • Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.
  • History of ocular trauma within the past 6 months.
  • Intraocular surgery within the past 3 months.
  • Ocular laser surgery within the past 3 months.
  • Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
  • Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients' history and/or examination.
  • History of or current clinically relevant or progressive retinal disease, such as retinal degeneration, diabetic retinopathy or retinal detachment.
  • Any abnormality preventing reliable applanation tonometry.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872651

China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Alcon Research

Responsible Party: Alcon Research Identifier: NCT00872651     History of Changes
Other Study ID Numbers: C-08-074
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013

Keywords provided by Alcon Research:
intraocular pressure

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents