A Clinical Trial to Study the Effectiveness and Safety of Brinzolamide 10 mg plus Timolol Maleate 5mg Ophthalmic Suspension compared with Dorzolamide 20mg plus Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open-Angle Glaucoma or Ocular Hypertension

Phase 3

Not yet recruiting

Conditions: Open-angle glaucoma, Open-Angle Glaucoma or Ocular Hypertension,

Registration Number: CTRI/2015/07/005976

Lead Sponsor: Ajanta Pharma Ltd

Brief Summary: This study is A Comparative, Randomized, Double blind, Parallel group and Multicentric clinical Study to Evaluate the Efficacy, Safety and Tolerability of Brinzolamide 10 -mg in Combination with Timolol Maleate 5mg Ophthalmic Suspension Vs. Dorzolamide 20mg plus Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open-Angle Glaucoma or Ocular Hypertension. The Study is proposed to start on 12.06.15. The following primary outcome will be measured at Day 1,at the end of 2nd, 6th, 9th and 12th week of treatment for clinical assessment: IOP (Intraocular pressure) Measurement by Goldmann Applanation Tonometry will be used as primary efficacy parameter. The secondary outcome will be measured as Eye pain, Eye redness, multicolored halos and headache will be graded and Safety assessments included solicited and unsolicited adverse events, corrected distance visual acuity, slit-lamp biomicroscopy, pachymetry, automated perimetry, fundus parameters, and resting pulse and blood pressure.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 232

Inclusion Criteria

1.Patient having clinical diagnosis of ocular hypertension.
2.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, Meiotic (7 days), Alpha Agonist and Alpha/beta agonist (14 days),Î² antagonist and prostaglandin analogs (28 days).
3.Subject with History of discontinued Carbonic anhydrase inhibitor of 2 months back.
4.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

Exclusion Criteria

1.Ocular trauma or intraocular surgery within the past 6 months.
2.Ocular infection, inflammation, or laser surgery within the past 3 months.
3.Chronic, recurrent or severe inflammatory eye disease 4.Central cornea thickness 620 mm, as measured by pachymetry, in either eye 5.Shaffer angle grade less than 2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, more thab 20]), as measured by Gonioscopy.
6.Severe central visual field loss in either eye measured by Perimetry.
7.Clinically significant or progressive retinal disease.
8.Best-corrected visual acuity worse than 0.6 logMAR (Best Corrected VA score worse than 55 ETDRS letters (20/80 Snellen equivalent)) 9.Other ocular pathology (including severe dry eye) that may preclude the administration of an alpha-adrenergic agonist and/or a topical CAI.
10.A history of hypersensitivity to brinzolamide and other sulphonamides, timolol, or any other component of the medication.
12.Patients suffering from sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
13.Patients suffering from severe allergic rhinitis and bronchial hyperreactivity.
14.Patients suffering from severe renal impairment (see Hepatic / Renal Impairment).
15.Patients who have participated in other clinical studies within 3 months.
16.Any condition which are likely to hinder the compliance with the protocol.
17.Patients should not take other topical or oral beta-blockers during the study period.
18.Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
19.Patients who are scheduled to undergo surgery of the opposite eye during the study period.
21.Significant visual field loss or evidence of progressive visual field loss within the last year.
22.Patients with recent use of high-dose (1 gm daily) salicylate therapy 23.Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
24.Cup/disc ratio greater than 0.80 25.History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitablefor the study.
26.Systemic administration of corticosteroids or immunosuppressive agents and local injection of corticosteroids in the eyes.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IOP (Intraocular pressure) Measurement by Goldmann Applanation Tonometry	Day 1, 2nd week, 6th week, 9th week, 12th week

Secondary Outcome Measures

Name	Time	Method
Eye pain, Eye redness, multicolored halos and headache will be graded by four point scale by the physician	Day 1, 2nd week, 6th week, 9th week, 12th week

Trial Locations

Locations (5): Dr. R.S.P.R. Government Regional Eye Hospital
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
King George Medical University
🇮🇳
Lucknow, UTTAR PRADESH, India
M.S Ramaiah Medical College
🇮🇳
Bangalore, KARNATAKA, India
Regional Institute Of Ophthalmology
🇮🇳
Kolkata, WEST BENGAL, India
Shashwat Hospital
🇮🇳
Pune, MAHARASHTRA, India
Dr. R.S.P.R. Government Regional Eye Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Dr Tarkeshwar Rao
Principal investigator
9441873644
tarakeye@gmail.com