Efficacy and tolerability of brinzolamide in patients with elevated intraocular pressure

• Conditions: MedDRA version: 14.1Level: PTClassification code 10022806Term: Intraocular pressure increasedSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Eye Diseases [C11]; intraocular pressure increased

• Registration Number: EUCTR2013-001793-21-HU
• Lead Sponsor: PHARMATHEN S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-15
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

[1]Elevated IOP and open angles (irideocorneal angle >30 grad) in at least one eye: mean diurnal IOP measured at -12, -8, –4, -0 hours pre-treatment (Day 1) must be > 22 mmHg, and = 35 mmHg (untreated, i.e. after washout) in the target eye. If both eyes have the same IOP, the investigator will select the target eye, using a right, left assignment. Otherwise, the eye with higher IOP will be used for analysis.
[2]18 years and older
[3]Patients with open angle glaucoma or ocular hypertension in at least one eye
[4]Patients who are both pre-treated or not pre-treated (patients in whom beta blockers are contraindicated or patients to whom it is used as adjunctive therapy to beta-blockers or prostaglandin analogues) with locally administered drugs for open angle glaucoma or ocular hypertension
[5]Patients with IOP between 22 and 35 mm Hg in both eyes at 8:00 a.m., 12:00 noon, and 4:00 p.m.
[6]Patients unresponsive to beta blockers or patients in whom beta blockers are contraindicated
[7]Patients with best corrected visual acuity of =20/100 (Snellen) or 2/10 (Monoyer)
[8] Patients with controlled arterial blood pressure according to the investigator’s opinion
[9]No systemic medication that may alter IOP in the previous 30 days (e.g. beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.), or expected to continue the current treatment with these medicinal products on a stable regimen for 30 days prior to the study and during the study.
[10]Female subjects of childbearing age who are using a medically accepted form of birth control and have a negative urine pregnancy test at screening
[11]Subjects with ability to follow study instructions and likely to attend and complete all required visits
[12]Signed and dated informed consent

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 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

[1]Monophthalmia or legal blindness in either eye.
[2]Pseudoexfoliative glaucoma or pigmentary glaucoma
[3]Congenital or secondary glaucoma
[4]History of angle closure
[5]Ocular inflammation or infection (apart of completely cured blepharoconjunctivitis) within the last 3 months before randomization and/or noninfectious conjunctivitis, keratitis, scleritis or uveitis in either eye at the screening visit
[6]Severe ocular trauma or surgery within the last 3 months before randomization
[7]Laser therapy for glaucoma or ocular hypertension within the last 3 months before randomization
[8]Xerophthalmia
[9]Damage or failure of the corneal endothelium
[10]Use of contact lenses for more than 2 hours per day
[11]Hypersensitivity to the active substance or any of the excipients of both study drugs
[12]Known hypersensitivity to sulphonamides
[13]Administration of any concomitant alternative topical or systemic treatment for glaucoma or ocular hypertension
[14]Administration of concomitant ocular corticosteroids or antibiotics
[15]Administration of concomitant oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
[16]Any of the following washout periods (time period between end of treatment with respective medication and randomization in the present trial) for previous treatments of glaucoma or ocular hypertension not fulfilled: 28 days for beta blockers or prostaglandins or carbonic anhydrase inhibitors,14 days for alpha or alpha/beta agonists, 5 days for miotics
[17]Patients on dialysis or with severe renal failure: glomerular filtration rate of less than 30 ml/min or serum creatinine above 240 µmol/l
[18]Hyperchloraemic acidosis
[19]Hepatic impairment (ALT, AST or total bilirubin more than 3 times above the upper limit of the reference range)
[20]Pregnancy or lactation
[21]Simultaneous participation in another clinical study or participation in any clinical study involving an investigational drug within 3 months prior to start of the present study
[22]Severe physical or mental concomitant diseases that might hamper the realization of the trial according to protocol
[23]Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
[24]Unreliability or lack of cooperation
[25]History of severe, unstable or uncontrolled cardiovascular (e.g., sinus bradycardia, overt cardiac failure, greater than first degree atrioventricular block, cardiogenic shock, clinically relevant angina or uncontrolled hypertension) or severe renal impairment
[26]Bronchial asthma or severe chronic obstructive pulmonary disease
[27]Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye
[28]Any corneal or retinal abnormality preventing reliable measurements by tonometry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): •Comparison of reductions in intraocular pressure at 8:00 a.m. in subjects treated with the test or reference product, characterized as an intra-individual difference in the target eye from baseline to the end of the treatment period (12 weeks).<br><br>Target eye is defined as the eye with the higher IOP. If both eyes have the same IOP, the investigator will select the target eye, using a right/left assignment.<br>;Main Objective: To evaluate the non-inferiority of eye drops containing brinzolamide 10 mg/ml (Brinzolamide Ophthalmic Suspension) as compared to a reference product (AZOPT® 10 mg/ml eye drops suspension) for the treatment of elevated intraocular pressure or open angle glaucoma. ;Secondary Objective: To compare the overall efficacy and safety of the two brinzolamide products (test and reference) in subjects with open angle glaucoma or ocular hypertension in at least one eye.;Timepoint(s) of evaluation of this end point: end of the treatment period (12 weeks)