A Clinical Trial to Study the Effectiveness and Safety of Brinzolamide 1.0% w/v plus Brimonidine Tartrate 0.2 % w/v Ophthalmic Suspension compared with Brinzolamide 1% eye drops for the Treatment of patients with Open-Angle Glaucoma or Ocular Hypertension.
- Conditions
- Open-angle glaucoma, Open-Angle Glaucoma or Ocular Hypertension,
- Registration Number
- CTRI/2015/07/006043
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
This study is a multicentric, double blind, randomized, active control, parallel group comparative 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. The Study is proposed to start on 12.06.15. The following primary outcome will be measured at Day 1,at the end of 1st 2nd, 4th, 8th and 12th week of treatment for clinical assessment: The mean reduction in IOP of the treatment groups will be assessed using descriptive statistics. The improvement in IOP from baseline to the end of treatment period will be compared by Chi square test. The secondary outcome will be measured as Percentage of patients reaching the defined IOP (intraocular pressure) <20 mmHg for general population, and ≤20 mmHg for elderly) at the final visit of the study and Percentage of patients reporting AE and/or SAE during thestudy.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 232
- •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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •The primary end point for assessing efficacy will be the reduction in IOP (Intraocular Pressure) measured by Tonometry 1st week, 2nd week, 4th week, 8th week, 12th week
- Secondary Outcome Measures
Name Time Method •Percentage of patients reporting AE and/or SAE during the study. 12th week •Percentage of patients reaching the defined IOP (intraocular pressure) 20 mmHg for general population, and ≤20 mmHg for elderly) 12th week
Trial Locations
- Locations (21)
Apollo first med Hospital
🇮🇳Chennai, TAMIL NADU, India
Aster Aadhar Hospital (Prerana Hospital Ltd.)
🇮🇳Kolhapur, MAHARASHTRA, India
Bhagwan Mahaveer Jain Hospital
🇮🇳Bangalore, KARNATAKA, India
Bhatia Hospital Medical Research Society
🇮🇳Mumbai, MAHARASHTRA, India
Dayanand Medical College & Hospital
🇮🇳Ludhiana, PUNJAB, India
Dr. D. Y. Patil Medical Hospital
🇮🇳(Suburban), MAHARASHTRA, India
Institute of Post Graduate Medical Education & Research
🇮🇳Kolkata, WEST BENGAL, India
IPGMER & SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
Kasturaba Medical College and Hospital
🇮🇳Mysore, KARNATAKA, India
King George Medical college
🇮🇳Lucknow, UTTAR PRADESH, India
Scroll for more (11 remaining)Apollo first med Hospital🇮🇳Chennai, TAMIL NADU, IndiaDr Mary AbrahamPrincipal investigator9841700824beulah.f@aherf-smo.org