CTRI/2020/09/027727
Completed
未知
A multicentre, randomized, assessor-blinded, active controlled, parallel group,two arm, bioequivalence study with clinical endpoint between Brinzolamide10 mg/ml plus Brimonidine tartrate 2 mg/ml eye drops suspension (PharmathenS.A, Greece) and Simbrinza (Brinzolamide 10 mg/ml Brimonidine tartrate2 mg/ml) eye drops suspension (Novartis Europharm Limited, Ireland) in thetreatment of elevated intraocular pressure in adult patients with open-angleglaucoma or ocular hypertension.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H49-H52- Disorders of ocular muscles, binocular movement, accommodation and refraction
- Sponsor
- Pharmathen SA
- Enrollment
- 204
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male and female patients, aged more than or equal to 18 years, 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 1 eye, the same eyes, must have been: more than or equal 24 mmHg and less than or equal 36 mmHg at the 9 a.m. time point, and more than or equal 21 mmHg and less than or equal 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 more than 36 mmHg in either eye at any time point.
- •3\. Adequate wash\-out period prior to baseline of any ocular hypotensive medication see Table 1\. In order to minimize potential risk to patients due to IOP elevations during the washout period, investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha\-agonist, beta\-adrenergic blocking agent, or prostaglandins. However, patients must have discontinued all ocular hypotensive medication for the minimum
- •washout period provided in Table 1\. In case, the patient was being treated with any ocular hypotensive medication containing two drugs, washout period of the drug having a longer washout period should be considered as washout period (e.g. combination of pilocarpine and betaxolol) where the washout should be considered as 4 weeks).
- •Table 1\. Medication Washout period Parasympathomimetics (e.g., pilocarpine, carbachol) 5 days wash out, Carbonic Anhydrase Inhibitors (systemic or topical) (e.g., acetazolamide, dorzolamide hydrochloride, brinzolamide) 5 days wash out ,Sympathomimetics (e.g., dipivefrin, epinephrine) 2 weeks wash out, Alpha\-agonists (e.g., apraclonidine, brimonidine tartrate, brimonidine tartrate and brinzolamide) 2 weeks wash out, Beta adrenergic blocking agents (e.g., timolol, timolol maleate and dorzolamide hydrochloride, timolol maleate and brimonidine tartrate, levobunolol, betaxolol, metipranolol, carteolol) 4 weeks, Prostaglandin analogs e.g., latanoprost, travoprost, bimatoprost, tafluprost 4 weeks wash out
- •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.
- •7\. Study patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required scheduled study visits.
- •8\. Patients must be able to safely discontinue use of all ocular hypotensive medications and undergo appropriate washout period.
Exclusion Criteria
- •1\. Pregnant or lactating females.
- •2\. Chronic, recurrent or severe inflammatory eye disease.
- •3\. Severe central visual field loss i.e. sensitivity less than or equal 10 dB in more than or equal 2 of the 4 visual field test points closest to the point of fixation in either eye.
- •4\. Schaffer angle grade less than 2 degree in either eye as measured by gonioscopy.
- •5\. Cup to disc ratio more than 0\.80 horizontal or vertical measurement in either eye.
- •6\. Best corrected visual acuity BCVA score worse than 55 ETDRS letters 20 by 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 in either eye.
- •9\. Ocular trauma within the preceding 6 months.
- •10\. Contraindication to brimonidine tartrate, brinzolamide or sulphonamide 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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