CTRI/2021/12/038477
Completed
未知
A multicentre, randomized, assessor-blinded, active controlled, parallel group, two arm, bioequivalence study with clinical endpoint to assess non-inferiority of Brimonidine tartrate 2 mg/ml & Timolol 5 mg/ml preservative-free eye drops solution (Pharmathen S.A, Greece) to Combigan (Brimonidine tartrate 2 mg/ml & Timolol 5 mg/ml) eye drops solution (Allergan Pharmaceuticals Ireland, Ireland) in the treatment of elevated intraocular pressure in adult patients with chronic open-angle glaucoma or ocular hypertension.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H409- Unspecified glaucoma
- Sponsor
- Pharmathen SA
- Enrollment
- 233
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female patients, aged ââ?°Â¥18 years, diagnosed with chronic open\-angle glaucoma or ocular hypertension, who in the opinion of the Investigator, were insufficiently controlled on monotherapy of topical beta\-blockers.
- •2\.Mean IOP measurements in at least 1 eye, the same eye(s), must have been:
- •Ã¢â?¬Â¢Ã¢â?°Â¥ 24 mmHg and ââ?°Â¤ 36 mmHg at the 9 a.m. time point, and
- •Ã¢â?¬Â¢Ã¢â?°Â¥ 21 mmHg and ââ?°Â¤ 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
- •Ã¢â?¬Â¢Mean IOP must not have been \> 36 mmHg in either eye at any time point.
- •3\.Best corrected visual acuity (BCVA) of 20/100 or better in each eye.
- •4\.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 gradually withdraw the ongoing ocular hypotensive medication and substitute a parasympathomimetic or carbonic anhydrase inhibitor (having shorter washout period) in place of sympathomimetics, alpha\-agonist, beta\-adrenergic blocking agent, topical prostaglandins and topical prostamides (having longer washout period) as per table 1\. 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).
- •5\.Patients must have provided IEC approved written informed consent using the latest version of the IEC informed consent form.
- •6\.Patients must be in good health and free from any clinically significant disease apart from indication under study.
- •7\.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 ââ?°Â¤10 dB in ââ?°Â¥2 of the 4 visual field test points closest to the point of fixation) in either eye.
- •4\.Schaffer angle grade \<2 in either eye (as measured by gonioscopy).
- •5\.Cup\-to\-disc ratio \>0\.80 (horizontal or vertical measurement) in either eye.
- •6\.Unable to safely discontinue IOP\-lowering ocular medications per the washout schedule.
- •7\.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.
- •8\.Ocular trauma within the preceding 6 months.
- •9\.Contraindication to brimonidine tartrate, timolol or sulfonamide therapy or known hypersensitivity to sulfonides or any component of brimonidine tartrate and timolol ophthalmic solution.
- •10\.Use of intraocular corticosteroid implant at any time prior to baseline.
Outcomes
Primary Outcomes
Not specified
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