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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Forcier, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01711177
First received: October 3, 2012
Last updated: June 16, 2016
Last verified: June 2016
  Purpose

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


Condition Intervention
Primary Open Angle Glaucoma
Drug: placebo
Drug: travoprost

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Blood Oxygenation [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    For each subject, all the measurements will be done during an 1 hour appointment.


Enrollment: 14
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Normal control
Normal patient placebo
Drug: placebo
Placebo
Sham Comparator: Glaucoma suspect
Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
Drug: placebo
Placebo
Experimental: Newly diagnosed glaucoma
Treated with Travoprost (0.04%)
Drug: travoprost
Travatan Z is administered to newly diagnosed glaucoma patient
Other Name: travatan

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  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: NCT01711177

Locations
Canada, Quebec
University of Montreal
Montreal, Quebec, Canada, H3t1P1
Sponsors and Collaborators
Université de Montréal
  More Information

Responsible Party: Pierre Forcier, Associate professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01711177     History of Changes
Other Study ID Numbers: OPM3117-Dubois/Pham 
Study First Received: October 3, 2012
Results First Received: June 16, 2016
Last Updated: June 16, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Montréal:
primary open angle glaucoma
retinal oximetry

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Travoprost
Antihypertensive Agents

ClinicalTrials.gov processed this record on July 27, 2016