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

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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004%/Timolol 0.5%; Drug: Latanoprost 0.005% / Timolol 0.5%

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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%	Drug: Latanoprost 0.005% / Timolol 0.5%; Latanoprost 0.005% / Timolol 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure (IOP)	Mean Diurnal Intraocular Pressure (IOP) (averaged at 9 AM, 11 AM and 4 PM) change from baseline at Week 8.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP)	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.	8 weeks

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: February 25, 2009
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (Estimate): March 31, 2009

Study Record Updates

• Last Update Posted (Estimate): March 28, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Glaucoma; intraocular pressure; timolol; travoprost/timolol
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Travoprost; Latanoprost
• Other Study ID Numbers: C-08-074