Ciracadian Ocular Perfusion and Ocular Blood Flow
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: AZARGA (Drug); COMBIGAN (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Alcon Research Overall contact:
Alcon Call Center, Phone: 1-888-451-3937
Summary
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.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Primary outcome: Diastolic ocular perfusion pressure
Secondary outcome: Circadian ocular perfusion pressure, ocular blood flow, IOP, blood pressure, ocular signs, visual acuity, dilated fundus adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Alcon Call Center, Phone: 1-888-451-3937
Contact Alcon Call Center For Trial Locations, Fort Worth, Texas 76134, United States; Recruiting
Alcon Call Center
Additional Information
Starting date: November 2008
Last updated: June 1, 2009
|
