A Clinical trial to study the efficacy, safety and tolerability of Brinzolamide 10 mg in combination with Timolol 5 mg Ophthalmic suspension vs Dorzolamide 20mg + Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open Angle Glaucoma or Ocular Hypertensionâ??

Ajanta Pharma Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male and Female patients of age 18 years and older.
•2.Patient having clinical diagnosis of ocular hypertension.
•3.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

•1.Male and Female patients of age less than 18 years.
•2.A history of hypersensitivity to brinzolamide and other sulphonamides, timolol, or any other component of the medication.
•3.Patients suffering from bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
•4.Patients suffering from sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
•5.Patients suffering from severe allergic rhinitis and bronchial hyperreactivity.
•6.Patients suffering from severe renal impairment (see Hepatic / Renal Impairment).
•7.Patients who have participated in other clinical studies within 3 months.
•8.Any condition which are likely to hinder the compliance with the protocol.
•9.Patients should not take other topical or oral beta-blockers during the study period.
•10.Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
•11.Eye surgery or laser treatment within 12 weeks prior to study enrollment.
•12.Patients who are scheduled to undergo surgery of the opposite eye during the study period.
•13.Patients who are required to wear contact lens during the study period.
•14.Significant visual field loss or evidence of progressive visual field loss within the last year.

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