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A 12 Week Comparison of DuoTrav and Xalacom in Open-Angle Glaucoma (DVX)

This study has been completed.
Alcon Research
Information provided by (Responsible Party):
Ophthalmic Consultants Centres, Canada Identifier:
First received: April 21, 2009
Last updated: April 20, 2015
Last verified: April 2015


  • H1: Efficacy of Duotrav will be superior to Xalacom at 24 hours post dosing when both medications are given in the morning
  • H2: A significant proportion of patients will prefer dosing of once daily topical fixed combination therapy in the morning compared to evening dosing

Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
Drug: DuoTrav (travoprost-timolol ophthalmic drops)
Drug: Xalacom (latanoprost-timolol ophthalmic drops)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A 12 Week Comparison of DuoTrav and Xalacom at 24 Hours Post-Dose in the Treatment of Open-Angle Glaucoma (the DVX Study)

Resource links provided by NLM:

Further study details as provided by Ophthalmic Consultants Centres, Canada:

Primary Outcome Measures:
  • IOP lowering efficacy of DuoTrav and Xalacom [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • To compare patient dosing preferences in terms of convenience and perceived compliance [ Time Frame: 12 weeks ]

Enrollment: 54
Study Start Date: January 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DuoTrav Drug: DuoTrav (travoprost-timolol ophthalmic drops)
topical ophthalmic drops instilled 1 drop daily
Other Name: DuoTrav
Active Comparator: Xalacom Drug: Xalacom (latanoprost-timolol ophthalmic drops)
topical ophthalmic drops instilled 1 drop daily
Other Name: Xalacom

Detailed Description:
  • Primary objective: Compare IOP-lowering efficacy of morning dosing of Duotrav to Xalacom.
  • Secondary objective: Compare patient dosing preferences for topical prostaglandin therapy in terms of convenience and perceived compliance.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients ≥ 18 years old, diagnosed with primary open angle glaucoma or ocular hypertension
  • IOP currently uncontrolled on beta blocker monotherapy, as judged by the investigator
  • Response to Timolol 0.5% was a ≥10% reduction in IOP
  • IOP at 9:00 of ≥ 20 mmHg while still on beta blocker
  • Non-prescription and prescription topical ophthalmic products and systemic medications other than those mentioned in the exclusion criteria will be allowed during the study.
  • Patients wearing contact lenses will be permitted to participate in the study provided that the contact lenses are removed during instillation of study medication and that the patient waits fifteen (15) minutes following drug instillation to re-insert the lenses. Contact lenses cannot be worn on study days.

Exclusion Criteria:

  • Best corrected visual acuity worse than 0.6 logMAR or 20/80 Snellen in either eye.
  • Patients in whom the mean IOP in either eye at the screening exam visit is greater than 36 mmHg
  • History of ocular trauma within the past six (6) months.
  • History of ocular infection or ocular inflammation within the past three (3) months.
  • History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis, uveitis)
  • History of severe or serious hypersensitivity to any components of the study medications.
  • Any abnormality preventing reliable applanation tonometry of either eye.
  • Intraocular surgery within the past six (6) months as determined by patient history and/or examination.
  • Patients with cup/disc ratio greater than 0.80 in either eye.
  • Patients with severe central visual field loss in either eye defined as a sensitivity 10 dB in at least two (2) of the four (4) visual field test points closest to the point of fixation.
  • History of severe retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
  • Current use of ANY glucocorticoid administered by any route. Patient must have washed out of the glucocorticoid for at least 4 weeks prior to study entry.
  • Use of any systemic prostaglandin or prostaglandin analogue (e.g., CYTOTEC) within the last three months.
  • Current use of topical non-steroidal anti inflammatory agents which inhibit cyclo-oxygenase and prostaglandin analogue synthesis.
  • Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component).
  • Current use of topical non-steroidal anti inflammatory agents which inhibit cyclo-oxygenase and prostaglandin analogue synthesis
  • Angle grade less than 2 (extreme narrow angle with complete or partial closure) as measured by gonioscopy.
  • Therapy with another investigational agent within the past 30 days
  • Patients who would be at risk from treatment with a topical prostaglandin or prostaglandin analogue, are contraindicated for use of beta-blockers or any other medication used in this study, or who would be at risk from participation in the study.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00887029

Canada, Ontario
Ophthalmic Consultant Centres
Mississauga, Ontario, Canada, L4W1W9
Dr David B. Yan, M.D., F.R.C.S.C.
Toronto, Ontario, Canada, M5R2M8
Sponsors and Collaborators
Ophthalmic Consultants Centres, Canada
Alcon Research
Principal Investigator: David B Yan, MD Ophthalmic Consultant Centres
Study Chair: Navroop Gill, OD Ophthalmic Consultant Centres
  More Information


Responsible Party: Ophthalmic Consultants Centres, Canada Identifier: NCT00887029     History of Changes
Other Study ID Numbers: OCC1023
Study First Received: April 21, 2009
Last Updated: April 20, 2015

Keywords provided by Ophthalmic Consultants Centres, Canada:
Topical prostaglandin analogue
ocular hypertension
fixed combination protaglandin analogue therapy
24 hour post dose
dosing preference

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Pharmaceutical Solutions processed this record on May 25, 2017