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

NCT01711177 | Completed Results DMC

• 1 other identifier: OPM3117-Dubois/Pham
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Open Angle Glaucoma

Keywords

primary open angle glaucoma; retinal oximetry

Outcome Measures

Primary Outcomes (1)

• Blood Oxygenation

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

  1 hour

Study Arms (3)

Normal control

SHAM COMPARATOR

Normal patient placebo

Drug: placebo

Glaucoma suspect

SHAM COMPARATOR

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

Drug: placebo

Newly diagnosed glaucoma

EXPERIMENTAL

Treated with Travoprost (0.04%)

Drug: travoprost

Interventions

placebo DRUG

Placebo

Glaucoma suspect; Normal control

travoprost DRUG

Travatan Z is administered to newly diagnosed glaucoma patient

Also known as: travatan

Newly diagnosed glaucoma

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

University of Montreal

Montreal, Quebec, H3t1P1, Canada

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Pierre Forcier
• Organization: Université de Montreal

pierre.forcier@umontreal.ca

514-343-7468

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 22, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 28, 2016
• Results First Posted: July 28, 2016

Record last verified: 2016-06

Locations

CA (1)