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

• ClinicalTrials.gov Identifier: NCT01711177
• Recruitment Status: Completed
• First Posted: October 22, 2012
• Results First Posted: July 28, 2016
• Last Update Posted: July 28, 2016
• Sponsor: Université de Montréal
• Information provided by (Responsible Party): Pierre Forcier, Université de Montréal

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

Condition or disease	Intervention/treatment	Phase
Primary Open Angle Glaucoma	Drug: placebo; Drug: travoprost	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma
• Study Start Date: October 2012
• Actual Primary Completion Date: March 2013
• Actual Study Completion Date: March 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Blood Oxygenation [ Time Frame: 1 hour ]
   For each subject, all the measurements will be done during an 1 hour appointment.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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
• Other Study ID Numbers: OPM3117-Dubois/Pham
• First Posted: October 22, 2012
• Results First Posted: July 28, 2016
• Last Update Posted: July 28, 2016
• Last Verified: June 2016

Keywords provided by Pierre Forcier, Université de Montréal:

primary open angle glaucoma; retinal oximetry

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases; Travoprost; Antihypertensive Agents