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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00872651
First received: February 25, 2009
Last updated: March 27, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Intraocular pressure (IOP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Mean Diurnal Intraocular Pressure (IOP) (averaged at 9 AM, 11 AM and 4 PM) change from baseline at Week 8.


Secondary Outcome Measures:
  • Intraocular Pressure (IOP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 242
Study Start Date: January 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872651

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00872651     History of Changes
Other Study ID Numbers: C-08-074
Study First Received: February 25, 2009
Last Updated: March 27, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma
intraocular pressure
travoprost/timolol
timolol

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Latanoprost
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 23, 2013