Health Condition 1: null- PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Conditions
Interventions
Intervention1: GENERIC BRINZOLAMIDE 1% OPHTHALMIC SUSPENSION: Brinzolamide belongs to a new class of heterocyclic sulfonamide CAIs that is topically active for reducing IOP. It has high affinity and i
Sponsors
InnoPharma Inc
Semler Research Center Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension (including pigment dispersion syndrome). 2. If of child bearing potential - • Must use a reliable means of contraception for the duration of the study or surgically sterilized. • Must have a negative pregnancy test. • Must be non-lactating 3. 9 am IOP measurements >= 24 4. The IOP criteria to be met by the same eye 5. Visual Acuity of 6/24 or better(or its equivalent by logMAR) in both eyes 6. Gonioscopy angle of >= 3 in both eyes 7. Patients with a level of understanding and willingness to fully comply with all visits and study procedures scheduled by the study site as evidenced by written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with any form of glaucoma other than open-angle glaucoma 2. Patients with Schaffer angle grade 3 (overall, however occludable angles treated with patent iridectomy are allowed ) 3. Patients with a cup/disc ratio greater than 0.8 4. Patients with severe central visual field loss 5. Best corrected VA score worse than 20/200 Snellen (equivalent to +1.0 log Mar) 6. Chronic, recurrent or severe inflammatory eye disease (blepharitis or clinically non-significant conjunctival hyperaemia allowed) 7. Clinically significant or progressive retinal disease or optic nerve disease from any cause apart from glaucoma 8. Other ocular pathology especially Fuchâ??s endothelial dystrophy, moderate to severe guttata, subjectively low endothelial cell count by slit lamp biomicrscopy or any abnormality preventing reliable applanation tonometry 9. Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist like MAO inhibitors. 10. History of hypersensitivity to oral or topical CAIs, sulfonamide drugs or to any component of these medications or the study medications or ingredients 11. Contact lens use during the active treatment portion of the trial. However if patient agrees to avoid use of contact lens use 15 minutes before and after drug administration, such patient can be included 12. Active ocular allergies. 13. Conventional ocular surgery or laser surgery within the 3 months prior to visit 1. 14. Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis. 15. Active ocular diseases or uncontrolled systemic disease. Patients requiring concomitant aggressive therapy with antihypertensives or steroids or patients on oral CAIs like acetazolamide or methazolamide. However patients on stable dose of antihypertensive therapy or stable doses of dermal or inhaled steroids can be allowed 16. Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control 17. Participation in any study during past 30 days 18. Relative or employee of the treating investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azoptâ?¢ (Brinzolamide 1% ophthalmic suspension).Timepoint: To establish that the generic Brinzolamide 1% ophthalmic suspension from InnoPharma Inc is therapeutically equivalent to the currently marketed Azoptâ?¢ (Brinzolamide 1% ophthalmic suspension). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety and efficacy of Brinzolamide 1% ophthalmic suspension in patients with primary open angle glaucoma or ocular hypertensionTimepoint: NA | — |
Countries
India, Malaysia, Singapore, Sri Lanka, United States of America
Contacts
Public ContactDr Leslie Ravi
Bangalore Diabetic Centre
Outcome results
None listed