CTRI/2023/06/054478
Completed
未知
A multicenter, randomized, assessor-blinded, active controlled, parallel group, two arm, non-inferiority clinical trial for the comparison of efficacy and safety of a preservative-free Brinzolamide 10mg/ml + Brimonidine tartrate 2 mg/ml eye drops suspension (AZAD Pharma AG, Switzerland) and Simbrinza® (Brinzolamide 10 mg/ml + Brimonidine tartrate 2 mg/ml) eye drops suspension (Novartis Europharm Limited, Ireland ) in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H401- Open-angle glaucoma
- Sponsor
- AZAD Pharma AG
- Enrollment
- 208
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female patients, aged 18\-75 years (both inclusive), diagnosed with bilateral or unilateral open\-angle glaucoma or ocular hypertension, who in the opinion of the Investigator, were insufficiently controlled on monotherapy or were already on multiple IOP lowering medications.
- •2\. Mean IOP measurements in at least one eye (the same eye), must have been:
- •? \= 24 mmHg and \= 36 mmHg at the 9 a.m. time point, and
- •? \= 21 mmHg and \= 36 mmHg at the 11 a.m. time point at both the Eligibility 1 and Eligibility 2 visits
- •following washout of any IOP\-lowering medication.
- •? Mean IOP must not have been \> 36 mmHg in either eye at any time point.
- •3\. Adequate wash\-out period prior to baseline of any ocular hypotensive medication.
- •4\. Patients must have provided IEC approved written informed consent using the latest version of the IEC informed consent form.
- •5\. Patients must be in good health and free from any clinically significant disease apart from indication under study.
- •6\. Patients able to comply with study procedures in the opinion of the investigator.
Exclusion Criteria
- •1\. Pregnant or lactating females.
- •2\. Chronic, recurrent or severe inflammatory eye disease.
- •3\. Severe central visual field loss (i.e., sensitivity \=10 dB in \=2 of the 4 visual field test points closest to the point of fixation) in either eye.
- •4\. Schaffer angle grade \<2 degree in either eye (as measured by gonioscopy).
- •5\. Cup\-to\-disc ratio \>0\.80 (horizontal or vertical measurement) in either eye.
- •6\. Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
- •7\. Unable to safely discontinue IOP\-lowering ocular medications per the washout schedule.
- •8\. Current or history within 3 months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, ocular inflammation, corneal ulcerin either eye or corneal foreign body.
- •9\. Ocular trauma within the preceding 6 months.
- •10\. Contraindication to brimonidine tartrate, brinzolamide or sulfonamide therapy or known hypersensitivity to sulfonides or any component of brimonidine tartrate and brinzolamide ophthalmic suspension.
Outcomes
Primary Outcomes
Not specified
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