A Multicenteric clinical study to compare Brinzolamide 1% Ophthalmic Suspension with Dorzox (Dorzolamide) 2% Ophthalmic Solution in treatment of Elevated Intra-Ocular Pressure in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

A Multicenter, Open Label, Active Control, Parallel-Group Randomized Study to Demonstrate Non Inferiority of Brinzolamide 1% Ophthalmic Suspension compared With Dorzox (Dorzolamide) 2% Ophthalmic Solution in Treatment of Elevated Intra-Ocular Pressure in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000578

Enrollment

200

Registered

2009-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Brinzolamide 1% ophthalmic suspension: 1 drop instilled in each eye, three times daily for 12 weeks Control Intervention1: Dorzox (dorzolamide) 2% ophthalmic solution: 1 drop instilled

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension. 2. IOP measurements &#8805; 24 &#8804; 36 mm Hg, in atleast one eye, at 9.00 am and &#8805; 21 &#8804; 36 mm Hg in atleast one eye (the same eye) at 11.00 am measurement

Exclusion criteria

Exclusion criteria: Patients with one sighted eye or amblyopia, history of chronic or recurrent inflammatory eye disease, ocular infections (3 months), ocular trauma, severe or progressive retinal or optic nerve disease, severe ocular pathology, intraocular surgery (last 12 months), laser surgery (last 3 months), current use of steroids or presence of any other form of glaucoma other than primary open angle glaucoma

Design outcomes

Primary

Measure	Time frame
IOP reduction from baselineTimepoint: 12 weeks	—

Secondary

Measure	Time frame
IOP reduction from baselineTimepoint: 4 and 8 weeks	—

Countries

India

Contacts

Public ContactVinod. M

Manipal Acunova

shalini.agarwal@ecronacunova.com91 80 - 66915776

Outcome results