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Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma

Primary Purpose

Primary Open Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
placebo
travoprost
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring primary open angle glaucoma, retinal oximetry

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • good systemic health
  • irido-corneal angle open
  • intraocular pressure more than 18 mmHg

Exclusion Criteria:

  • having cardiovascular problem
  • Hypertension or diabetes
  • under systemic medication for high blood pressure
  • had an ocular surgery in the past

Sites / Locations

  • University of Montreal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Sham Comparator

Experimental

Arm Label

Normal control

Glaucoma suspect

Newly diagnosed glaucoma

Arm Description

Normal patient placebo

Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)

Treated with Travoprost (0.04%)

Outcomes

Primary Outcome Measures

Blood Oxygenation
For each subject, all the measurements will be done during an 1 hour appointment.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2012
Last Updated
June 16, 2016
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT01711177
Brief Title
Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma
Official Title
Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Glaucoma is the second leading cause of blindness among seniors in Canada. It is often associated with an elevated intraocular pressure (IOP), but its exact mechanism is still largely unknown. Some studies have shown a link between glaucoma and changes in the amount of oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular veins among three different groups using a spectrophotometer. This instrument is linked to a camera and can measure the quantity of oxygen in the veins using different characteristics of the blood inside. The groups of the study are: patients without glaucoma, patients suspected of glaucoma and patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost 0.004%, will only be administered to the groups suspected or diagnosed with glaucoma. Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten patients will be recruited into each group for a total of 30 patients in this study. All patients for the suspected or diagnosed groups will be recruited from the Jewish General Hospital. Subsequently all testing will be done at the École d'optométrie, Université de Montréal

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
primary open angle glaucoma, retinal oximetry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal control
Arm Type
Sham Comparator
Arm Description
Normal patient placebo
Arm Title
Glaucoma suspect
Arm Type
Sham Comparator
Arm Description
Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
Arm Title
Newly diagnosed glaucoma
Arm Type
Experimental
Arm Description
Treated with Travoprost (0.04%)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
travoprost
Other Intervention Name(s)
travatan
Intervention Description
Travatan Z is administered to newly diagnosed glaucoma patient
Primary Outcome Measure Information:
Title
Blood Oxygenation
Description
For each subject, all the measurements will be done during an 1 hour appointment.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: good systemic health irido-corneal angle open intraocular pressure more than 18 mmHg Exclusion Criteria: having cardiovascular problem Hypertension or diabetes under systemic medication for high blood pressure had an ocular surgery in the past
Facility Information:
Facility Name
University of Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3t1P1
Country
Canada

12. IPD Sharing Statement

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Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma

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