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

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: NCT00887029
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : April 21, 2015
Alcon Research
Information provided by (Responsible Party):
Ophthalmic Consultants Centres, Canada

Brief Summary:


  • 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 or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: DuoTrav (travoprost-timolol ophthalmic drops) Drug: Xalacom (latanoprost-timolol ophthalmic drops) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (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)
Study Start Date : January 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Timolol

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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): NCT00887029

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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
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Principal Investigator: David B Yan, MD Ophthalmic Consultant Centres
Study Chair: Navroop Gill, OD Ophthalmic Consultant Centres

Publications of Results:

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Responsible Party: Ophthalmic Consultants Centres, Canada Identifier: NCT00887029     History of Changes
Other Study ID Numbers: OCC1023
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 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:
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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