Ciracadian Ocular Perfusion and Ocular Blood Flow

This study is not yet open for participant recruitment.

Verified by Alcon Research, December 2008

First Received: December 1, 2008 No Changes Posted

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00800540

Purpose

Compare the short term effects of two IOP-lowering medications on ocular perfusion pressure, ocular blood flow, circadian IOP and blood pressure in patients with glaucoma.

Condition	Intervention	Phase
Glaucoma	Drug: AZARGA Drug: COMBIGAN	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Diastolic ocular perfusion pressure [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Circadian ocular perfusion pressure, ocular blood flow, IOP, blood pressure, ocular signs, visual acuity, dilated fundus adverse events

Estimated Enrollment:	36
Study Start Date:	November 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental AZARGA	Drug: AZARGA Brinzolamide 10 mg/ml / Timolol 5 mg/ml, Eye drops, suspension
2: Active Comparator COMBIGAN	Drug: COMBIGAN Brimonidine 2 mg/ml / Timolol 5 mg/ml, Eye drops, solution

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
Either sex
Open-Angle Glaucoma in at least one eye
Requiring more than one IOP lowering medication
Mean IOP ≥ 23 mmHg at one time point during Eligibility/Baseline Visit (7 IOP measurements) and ≤ 32 mmHg at all time points at screening, safety, eligibility/Period 1 Baseline Visits

Exclusion Criteria:

Severe central visual field loss in either eye
Shaffer angle grade < III
Cup/disc ratio > 0.8 in either eye
Previous glaucoma surgery
Intraocular surgery < 3 months
Best-corrected VA > 0,6 logMAR
Contact lens wear
Allergy/hypersensitivity to study medication
Glucocorticoid must be discontinued 4 weeks prior to the screening visit and not be used during the study
Cardiovascular disease or uncontrolled hepatic, renal diseases that would require use of medications that could affect IOP or blood pressure
Medication that could affect IOP or Blood Pressure
Recent use (< 4 weeks prior to the study) of aspirin (> 1 gram)
Bronchial asthma or severe chronic obstructive pulmonary disease
Diabetic retinopathy
Any abnormality preventing reliable tonometry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800540

Contacts

Contact: Alcon Call Center

1-888-451-3937

Locations

United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Responsible Party:	Alcon ( Severine Durier/Study Manager )
Study ID Numbers:	C-07-16, eudract Number 2007-005936-99
Study First Received:	December 1, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00800540 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Alcon Research:

glaucoma
ocular perfusion pressure
ocular blood flow
open angle glaucoma requiring more than one IOP-lowering medication

Study placed in the following topic categories:

Brinzolamide
Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Timolol

Tetrahydrozoline
Brimonidine
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on May 07, 2009