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

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by:
Ophthalmic Consultants Centres, Canada
ClinicalTrials.gov Identifier:
NCT00887029
First received: April 21, 2009
Last updated: August 15, 2011
Last verified: April 2009
  Purpose

Hypothesis:

  • 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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare patient dosing preferences in terms of convenience and perceived compliance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887029

Locations
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 Laboratories
Investigators
Principal Investigator: David B Yan, MD Ophthalmic Consultant Centres
Study Chair: Navroop Gill, OD Ophthalmic Consultant Centres
  More Information

Publications:

Responsible Party: Dr David B. Yan, M.D., F.R.C.S.C., Ophthalmic Consultant Centres
ClinicalTrials.gov Identifier: NCT00887029     History of Changes
Other Study ID Numbers: OCC1023
Study First Received: April 21, 2009
Last Updated: August 15, 2011
Health Authority: Canada: Health Canada

Keywords provided by Ophthalmic Consultants Centres, Canada:
Topical prostaglandin analogue
glaucoma
POAG
OHT
OAG
ocular hypertension
fixed combination protaglandin analogue therapy
DuoTrav
timolol
travoprost
24 hour post dose
IOP
dosing preference

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Ophthalmic Solutions
Timolol
Travoprost
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014