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

• Sponsor: Université de Montréal (Other)
• Overall Status: Completed
• CT.gov ID: NCT01711177
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 2.8

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Oct 1, 2012
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 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 Names: travatan

Outcome Measures

Primary Outcome Measures

1. Blood Oxygenation [1 hour]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	University of Montreal	Montreal	Quebec	Canada	H3t1P1

Sponsors and Collaborators

• Université de Montréal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pierre Forcier, Associate professor, Université de Montréal
• ClinicalTrials.gov Identifier: NCT01711177
• Other Study ID Numbers: OPM3117-Dubois/Pham
• First Posted: Oct 22, 2012
• Last Update Posted: Jul 28, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Pierre Forcier, Associate professor, Université de Montréal: primary open angle glaucoma; retinal oximetry
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Travoprost

Study Results

Participant Flow

Arm/Group Title	Normal Control	Glaucoma Suspect	Newly Diagnosed Glaucoma
Arm/Group Description	Normal patient placebo placebo: Placebo	Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) placebo: Placebo	Treated with Travoprost (0.04%) travoprost: Travatan Z is administered to newly diagnosed glaucoma patient
Period Title: Overall Study
STARTED	10	3	3
COMPLETED	10	3	3
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Normal Control	Glaucoma Suspect	Newly Diagnosed Glaucoma	Total
Arm/Group Description	Normal patient placebo placebo: Placebo	Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) placebo: Placebo	Treated with Travoprost (0.04%) travoprost: Travatan Z is administered to newly diagnosed glaucoma patient	Total of all reporting groups
Overall Participants	10	3	3	16
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	3 100%	2 66.7%	15 93.8%
>=65 years	0 0%	0 0%	1 33.3%	1 6.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (5)	53 (8)	60 (9)	55 (10)
Sex: Female, Male (Count of Participants)
Female	5 50%	2 66.7%	2 66.7%	9 56.3%
Male	5 50%	1 33.3%	1 33.3%	7 43.8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Control	Glaucoma Suspect	Newly Diagnosed Glaucoma
Arm/Group Description	Normal patient placebo placebo: Placebo	Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) placebo: Placebo	Treated with Travoprost (0.04%) travoprost: Travatan Z is administered to newly diagnosed glaucoma patient
Measure Participants	10	3	3
Mean (95% Confidence Interval) [percentage of oxygenation]	60	60	60

Adverse Events

Time Frame	6 month
Arm/Group Title	Normal Control		Glaucoma Suspect		Newly Diagnosed Glaucoma
Arm/Group Description	Normal patient placebo placebo: Placebo		Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) placebo: Placebo		Treated with Travoprost (0.04%) travoprost: Travatan Z is administered to newly diagnosed glaucoma patient
All Cause Mortality
	Normal Control		Glaucoma Suspect		Newly Diagnosed Glaucoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Normal Control		Glaucoma Suspect		Newly Diagnosed Glaucoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/3 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Normal Control		Glaucoma Suspect		Newly Diagnosed Glaucoma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/3 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.