Open-angle glaucoma or ocular hypertension
Conditions
Interventions
Trade Name: Azarga
Product Name: not applicable
Product Code: not applicable
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: BRINZOLAMIDE
CAS Number: 138890-62-7
Concentration unit: m
Sponsors
Alcon d.o.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient must: 1. Be at least 18 years of age. 2. Have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. 3. Be on stable regimen IOP lowering medication within 30 days of 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 be willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the course of the study. 6. Must be able to follow instructions and be willing and able to attend all study visits. 7. 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
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. Best corrected visual acuity that is worse than 20/80 Snellen in either eye. 3. Any abnormality preventing reliable applanation tonometry in either eye. 4. Corneal dystrophies. 5. Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye. 6. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed. 7. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit. 8. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment. 9. Progressive retinal or optic nerve disease from any cause. 10. A history of, or at risk for uveitis or cystoid macular edema (CME). 11. History of ocular herpes simplex. 12. Use of any topical carbonic anhydrase inhibitor (single or fixed combination) within a year of the Screening Visit. 13. 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. 14. 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. 15. 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. 16. Any clinically significant, serious, or severe medical or psychiatric condition. 17. Women of childbearing potential not using reliable means of birth control 18. Women who are pregnant or lactating 19. 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. 20. Participation in any other investigational study within 30 days prior to the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary statistical objective is to demonstrate the patient preference for Azarga is superior to that of Cosopt with respect to ocular comfort in patients with open-angled glaucoma or ocular hypertension.;Secondary Objective: not applicable;Primary end point(s): Patient preference will be assessed through a patient preference questionnaire to be administered after patients have dosed with study medication on Day 2. The primary efficacy parameter is the percentage of patients with a stated preference for either stdy medication. Difference in the ocular discomfort of the two study medications will be investigated as a secondary efficacy measure. Patients will complete an ocular discomfort scale on the Day 1 and Day 2 visits, approximately 1 minute after instillation of study medication. | — |
Countries
Slovenia
Outcome results
None listed