Health Condition 1: H401- Open-angle glaucoma Health Condition 2: null- Open-Angle Glaucoma or Ocular Hypertension
Conditions
Interventions
Intervention1: Brinzolamide 1.0% w/v plus Brimonidine Tartrate 0.2 % w/v Ophthalmic Suspension: 1-2 drops twice daily in affected eye(s) for 12 weeks.
Control Intervention1: Brinzolamide 1% eye drop:
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: •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), β 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢The primary end point for assessing efficacy will be the reduction in IOP (Intraocular Pressure) measured by TonometryTimepoint: 1st week, 2nd week, 4th week, 8th week, 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Percentage of patients reaching the defined IOP (intraocular pressure) 20 mmHg for general population, and â?¤20 mmHg for elderly)Timepoint: 12th week;â?¢Percentage of patients reporting AE and/or SAE during the study.Timepoint: 12th week | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd
Outcome results
None listed