THE EFFICACY AND SAFETY OF TIMOLOL MALEATE 0.5% COMPARED TO BRINZOLAMIDE 1% EACH GIVEN TWICE DAILY WHEN ADDED TO TRAVOPROST 0.004% GIVEN EACH EVENING IN PRIMARY OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSIVE PATIENTS
- Conditions
- Increased intraocular pressure and glaucoma
- Registration Number
- EUCTR2005-004201-29-HU
- Lead Sponsor
- Alcon Hungarian ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 170
18 years of age or older
willingness to comply with the investigator's and protocol's instructions
patient's signature on the Institutional Review Board approved informed consent document (each patient should be given ample time to read (or have read to them) the consent form, ask any questions they may have regarding the trial and have a clear understanding of the trial and the procedures involved prior to the signing of the consent form).
have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
the intraocular pressure must be considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
in eyes not included in the study the intraocular pressure should be able to be controlled to a safe level on no pharmacologic therapy or study drug(s) only during the trial.
patients must have been treated with travoprost once daily as monotherapy for a minimum of 6 weeks at Visit 1 and have an intraocular pressure of between18 and 32 mm Hg inclusive in at least one eye and < 32 mm Hg in both eyes.
at baseline vsit the intraocular pressure should be between 18 and 32 mm Hg inclusive at the 08:00H measurement (Visit 2) in at least one eye and < 32 mm Hg at all time points in both eyes.
isual acuity should be 6/60 or better in both eyes.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
presence of exfoliation syndrome or exfoliation glaucoma
any abnormality preventing reliable applanation tonometry in study eye(s)
any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber in the study eye
any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
females of childbearing potential not using reliable means of birth control
pregnant or lactating females
any clinically significant, serious, or severe medical or psychiatric condition
participation (or current participation) in any investigational drug or device trial within the previous 30 days prior to the screening visit (Visit 1)
intraocular conventional surgery or laser surgery within the past three months in the study eye(s)
according to the investigator’s best judgment risk of visual field or visual acuity worsening as a consequence of participation in the trial
inability to understand the trial procedures, and thus inability to give informed consent
any anticipated change in systemic hypotensive therapy during the active treatment portion of the trial (Visits 1-4) which might include adjustments to oral ß-adrenergic blockers, ?-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers
progressive retinal or optic nerve disease from any cause
unwillingness to accept the risk of iris color or eyelash changes
a history of, or at risk for, uveitis or cystoid macular edema (CME) in this trial
history of ocular herpes simplex
contraindications to ?-blocker therapy including: reactive airway disease, secondary or third degree heart block, bradyarrhythmias, and uncontrolled heart failure
history of sulfa allergy
Fuch’s corneal dystrophy, moderate or severe guttata, or a subjectively low endothelial cell count by slit lamp biomicroscopy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to compare the efficacy and safety of timolol maleate 0.5% compared to brinzolamide 1% each given twice daily when added to travoprost 0.004% given each evening.;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method