An Open Label, Multicentric, Phase III, Prospective study to evaluate the efficacy, safety and tolerability of triple fixed dose combination of Timolol 0.5% Brimonidine 0.2% Brinzolamide 1% eye drops in patients with Open angle glaucoma or ocular hypertension not responding to dual drug therapy - NA

Micro Labs Limited0 个研究点目标入组 210 人开始时间: 待定最近更新: 2023年1月9日

试验速览

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•1.Subjects >=18 years of age of both gender
•2.Diagnosed with unilateral or bilateral open angle glaucoma (including pseudo exfoliation or pigment dispersion) or ocular hypertension
•3.Subjects who are already on dual drug therapy on any two of the following anti-glaucoma drugs, Timolol (0.5%), Brimonidine (0.1% or 0.2%), Brinzolamide (1%) /Dorzolamide (2%) eye drops with IOP of 22-32 mmHg in at least one eye
•4.Best Corrected Visual Acuity (BCVA) of 6/24 or better in study eye(s)
•5.Gonioscopy angle of >=2 in the study eye (s)
•6.In case of women, postmenopausal ( >12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures
•7.Willing to complete all study-related procedures
•8.Ability to understand and the willingness to sign and date a written informed consent document at the screening visit before any protocol specific procedures are performed.

•1.Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
•2.Clinically significant or progressive retinal disease (i.e. retinal degeneration, diabetic retinopathy, retinal detachment or retinal tears) or optic nerve disease.
•3.Ocular laser surgery within the 3 months prior to entry.
•4.Any abnormality preventing reliable applanation tonometry.
•5.Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
•6.Recent use of high-dose ( >1 gram daily) salicylate therapy.
•7.Subject with known allergy or hypersensitivity to the components of the formulation
•8.Participation in another clinical trial within past 30 days
•9.Other protocol-specified exclusion criteria may apply

发起方