Assessing the safety and efficacy of switching to Azarga (Brinzolamide/Timolol Fixed Combination), as replacement therapy in patients with uncontrolled intraocular pressure - not applicable

Phase 1

• Conditions: uncontrolled intraocular pressure

• Registration Number: EUCTR2009-015795-10-SI
• Lead Sponsor: Alcon d.o.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-30
• Last Update Posted: 10 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients MUST meet the following conditions to qualify for enrollment into the study:
1.Must be at least 18 years of age.
2.Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
3.Must be on a stable regimen IOP lowering medication (either a single therapeutic agent or two separate ocular hypotensive agents) within 1 week of the Screening Visit.
4.Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
5.Must have an IOP of between 19 to 35 mmHg in at least one eye (with would be the study eye). In the eye that is not included in the study, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
6.Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
7.Must be able to follow instructions and be willing and able to attend all study visits.
8.Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
9.An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.

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

Exclusion Criteria

Patients who meet any of the following conditions below will be excluded from this study:
1.Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
2.Any abnormality preventing reliable applanation tonometry in either eye.
3.Corneal dystrophies.
4.Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
5.Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
6.Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
7.Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
8.Progressive retinal or optic nerve disease from any cause.
9.A history of, or at risk for uveitis or cystoid macular edema (CME).
10.History of ocular herpes simplex.
11.Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
12.Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
13.Sinus bradycardia (< 50 beats per minute), second- or third-degree atrioventricular block, sino-atrial block, overt cardiac failure, or cardiogenic shock that would preclude the safe administration of a topical beta-blocker.
14.Any clinically significant, serious, or severe medical or psychiatric condition.
15.Women of childbearing potential.
16.Women who are pregnant or lactating.
17.A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
18.Participation in any other investigational study within 30 days prior to the Screening Visit.

Study & Design

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