Health Condition 1: null- Primary open angle glaucoma or ocular hypertension
Conditions
Interventions
Intervention1: Brinzolamide Ophthalmic suspension 1%, Manufactured by: Indoco Remedies, Ltd for Watson Pharma Pvt. Ltd: Each study subject will use 1 drop of test drug (Brinzolamide Ophthalmic Suspens
Sponsors
Watson Pharma Pvt Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant females aged at least 18 to 65 years inclusive and BMI of 18.5 to 30 Kg/m2, with chronic open angle glaucoma or ocular hypertension in both eyes on stable ocular hypotensive treatment regimen. 2. Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. 3. Adequate wash-out period prior to baseline of any ocular hypotensive medication. 4. Baseline (Day 0/hour 0) IOP >= 22 mm Hg and 5. Baseline best corrected visual acuity equivalent to 20/200 or better in each eye. 6. Study subjects must have provided IEC/IRB approved written informed consent. In addition, all study subjects must sign a HIPAA authorization, if applicable. 7. Study subjects should be literate and willing to complete the subject diary regularly as directed. 8. Study subjects must be in good health and free from any clinically significant disease apart from indication under study. 9. Females of child bearing potential (WOCBP) must not be pregnant or lactating at baseline visit (as documented by a negative serum pregnancy test with a minimum sensitivity of 25 IU/L or equivalent units of beta-human chorionic gonadotropin (Beta-HCG) at screening and urine pregnancy at baseline. 10. Female subjects of childbearing potential must be willing to use an acceptable form of birth control from the day of the first dose administration to 30 days after the last administration of study drug. 11. All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration (to 30 days after the last administration of study drug). 12. Study subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. 13. Study subjects must be willing to refrain from using any other treatments for COAG, other than the investigational product.
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, breast feeding, or planning a pregnancy during the course of the study and for 30 days after last study dose 2. Females of childbearing potential who do not agree to utilize an adequate form of contraception. 3. Current or past history of severe hepatic or renal impairment 4. Current or history within two months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye 5. Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer e.g. corneal dystrophy, corneal abrasions, corneal ulcers, keratitis, keratoconus and keratoglobus. 6. Functionally significant visual field loss 7. Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy 8. Use at any time prior to baseline of intraocular corticosteroid implant. 9. Use within one week prior to baseline of contact lens 10. Use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid 11. Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy 12. Use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid 13. Underwent within six months prior to baseline any other intraocular surgery (e.g., cataract surgery) 14. Underwent within twelve months prior to baseline: refractive surgery, filtering surgery or laser surgery for IOP reduction 15. Amblyopia - only one sighted eye 16. Severe retinal disease or other severe ocular pathology, such as glaucomatous damage with a cup/disk ratio greater than 0.8, split fixation, or functionally significant (in the investigatorsâ?? opinion) visual field loss 17. History or presence of significant alcoholism or drug abuse in the past one year 18. History or presence of significant smoking (more than 10 cigarettes or bidis/day or consumption of tobacco products) 19. History of hematologic disorders other than mild anemia 20. Severe, unstable, or uncontrolled cardiovascular or pulmonary disease 21. Systolic blood pressure less than 90 mm Hg or more than 140 mm Hg, Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50 beats/minute or more than 100 beats/minute 22. Any form of glaucoma other than chronic open-angle glaucoma 23. Therapy with an investigational agent within the past 30 days 24. Clinically significant hematologic and / or biochemical abnormalities based on laboratory testing 25. Positive serology test for hepatitis B, hepatitis C, HIV or syphilis. 26. Patients who are in the investigators best judgment at risk of visual field or visual acuity worsening as a consequence of participation of trial. 27. Chronic use of any systemic medication that may affect IOP with less than one month stable dosing regimen (i.e., sympathomimetic agents, beta-adrenergic blocking agents, alpha agonists, alpha-adrenergic blocking agents, calcium channel blockers, angiotensin -converting enzyme inhibitors, etc.) 28. Use of any prescribed medication during last two weeks or OTC medicinal products during the last one week preceding the first dosing that is aff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the bioequivalence of the efficacy and safety of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd., for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension in the treatment of chronic open angle glaucoma or ocular hypertension in both eyesTimepoint: Each study subject will use 1 drop of test or reference Ophthalmic Suspension in both the eyes 3 times daily at approximately 8:00, 16:00 and 22:00 hours for 42 days (6 weeks). The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject primary endpoint evaluation will be assessed after 2 weeks & 6 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Sumit Arora
Lotus Labs Pvt. Ltd.
Outcome results
None listed