A Clinical Study to evaluate the Efficacy , Safety and Tolerability of Brinzolamide 1.0% w/v plus Brimonidine Tartrate 0.2 % w/v Ophthalmic Suspension Vs. Brinzolamide 1% eye drops in patients with Open-Angle Glaucoma or Ocular Hypertension

Ajanta Pharma Ltd0 个研究点目标入组 232 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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•A clinical diagnosis of glaucoma or Ocular hypertension at least in at one (study) eye.
•IOP between 21 to less tnan and equal 36 mm of Hg.
•Freshly diagnosed patients of open angle glaucoma or ocular hypertension, Patients who are previously diagnosed and on treatment for open angle glaucoma or ocular hypertension will undergo washout period, Miotics (7 days), Alpha Agonist and Alpha/beta agonist (14 days), Î² antagonist and prostaglandin analogs (21 days).
•Subject with H/O discontinued Carbonic anhydrase inhibitor since past 4 months.
•Voluntary willingness to give written informed consent prior to participation in trial.

•Any history of:
•Ocular trauma or intraocular surgery within the past 6 months;
•Ocular infection, inflammation, or laser surgery within the past 3 months;
•Any present observation of:
•Chronic, recurrent or severe inflammatory eye disease.
•Central cornea thickness 620 mm, as measured by pachymetry, in either eye.
•Shaffer angle grade less than 2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, more than 20]), as measured by Gonioscopy.
•Severe central visual field loss in either eye measured by Perimetry.
•Clinically significant or progressive retinal disease.
•Best-corrected visual acuity worse than 0.6 logMAR (Best Corrected VA score worse than 55 ETDRS letters (20/80 Snellen equivalent).
•Other ocular pathology (including severe dry eye) that may preclude the administration of an alpha-adrenergic agonist and/or a topical CAI.
•Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
•Patients who are required to wear contact lens during the study period.
•Cup/disc ratio greater than 0.80.

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