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

April 20, 2015 updated by: Ophthalmic Consultants Centres, Canada

A 12 Week Comparison of DuoTrav and Xalacom at 24 Hours Post-Dose in the Treatment of Open-Angle Glaucoma (the DVX Study)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L4W1W9
        • Ophthalmic Consultant Centres
      • Toronto, Ontario, Canada, M5R2M8
        • Dr David B. Yan, M.D., F.R.C.S.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DuoTrav
Drug: DuoTrav (travoprost-timolol ophthalmic drops)
topical ophthalmic drops instilled 1 drop daily
Other Names:
  • DuoTrav
Active Comparator: Xalacom
Drug: Xalacom (latanoprost-timolol ophthalmic drops)
topical ophthalmic drops instilled 1 drop daily
Other Names:
  • Xalacom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IOP lowering efficacy of DuoTrav and Xalacom
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare patient dosing preferences in terms of convenience and perceived compliance
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthalmic Consultants Centres, Canada

Collaborators

Alcon Research

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCC1023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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