EUCTR2022-002524-12-BG
Active, not recruiting
Phase 1
A prospective, phase III, multicenter, randomized, investigator-blinded, two-arm, parallel groups, non-inferiority clinical trial for the comparison of efficacy and safety of a preservative-free Brinzolamide 10mg/ml eye drops suspension (Brinzolamide 10mg/ml Eye Drops Suspension Preservative Free) as a test product versus AZOPT® 10 mg/ml eye drops suspension as reference product in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension
DrugsAZOPT
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AZAD Pharma AG
- Enrollment
- 244
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female patients aged between 18 and 75 years at time of
- •Informed Consent;
- •Elevated IOP / primary open angle glaucoma (irideocorneal angle \>
- •30°) in at least one eye: mean diurnal IOP pre\-treatment (measured at
- •approximately 8 am and 10 am must be equal or higher than 22 mmHg,
- •and equal or lower to 35 mmHg (untreated, i.e. naïve or after washout);
- •In case of bilateral open\-angle glaucoma/ocular hypertension the
- •difference of IOP between both eyes is \=5 mmHg;
- •Best Corrected Visual Acuity (BCVA) 20/100 (Snellen chart)
- •(corresponding to logMAR score of \= \+ 0\.7 LogMar or \= 0\.2 in decimal
Exclusion Criteria
- •Advanced glaucoma defined by horizontal and vertical cup/disc ratio
- •(C/D) \>0\.8 in either (OR the affected) eye at Screening;
- •Visual field loss in either (OR the affected) eye (sensitivity \=10
- •decibel \[dB] in at least 2 of the 4 visual field test points closest to the
- •point of fixation), measured within 6 months prior to Screening, which in
- •the opinion of the investigator is functionally significant;
- •Central Corneal Thickness (CCT) \>620um in either (OR the affected)
- •eye as measured by pachymetry;
- •Patients with very narrow angles (3 quadrants with less than Grade 2
- •according to Shaffer's anterior chamber angle grading system) and
Outcomes
Primary Outcomes
Not specified
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