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About
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories, Inc. in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.
Full description
Study will be conducted in adult subjects, above 18 years inclusive, males and non pregnant females, diagnosed with chronic open angle glaucoma or ocular hypertension in both eyes. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0/hour 0 i.e., 8:00 am) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
Each study subject will use one drop of test or reference Ophthalmic Suspension in both the eyes three times daily at approximately 8:00am, 04:00 pm and 10:00 pm for 42 days (6 weeks). The dose and mode of treatment chosen in this study is the dosage approved by United States Food and Drug administration (US FDA) for use in treatment of patients of Chronic Open Angle Glaucoma.
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 (14 days) and 6 weeks (42 days) of treatment for each study subject deemed eligible for evaluation, (i.e., at Visit III - Day 14 ± 2 days and Visit IV - Day 42 ± 3 days).
The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes at four time points, i.e., at approximately 8:00 am and 10:00 am at the Day 14 (± 2 days) and Day 42 (± 3 days) visits.
Enrollment
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Inclusion criteria
Male or non-pregnant females aged 18 years and above with a Body Mass Index (BMI) of 18.5 to 35 Kg/m2, with chronic open angle glaucoma or ocular hypertension in both eyes on stable ocular hypotensive treatment regimen.
Subjects requiring treatment of both eyes and are able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.
Adequate wash-out period prior to baseline of any ocular hypotensive medication. In order to minimize potential risk to subjects due to IOP elevations during the washout period, investigator may choose to substitute a parasympathomimetic or carbonic anhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergic blocking agent, or prostaglandins. However, subjects must have discontinued all ocular hypotensive medication for the minimum washout period.
Baseline (Day 0/hour 0) IOP ≥ 22 mm Hg and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.
Baseline best corrected visual acuity equivalent to 20/200 or better in each eye.
Study subjects must have provided IRB approved written informed consent using the latest version of the IRB informed consent form. In addition, study subjects must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable.
Study subjects should be literate and willing to complete the subject diary regularly as directed.
Study subjects must be in good health and free from any clinically significant disease apart from indication under study.
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.
*All female subjects will be considered to be of childbearing potential unless they are postmenopausal. Female subjects of childbearing potential (WOCBP) are defined as sexually mature women without prior hysterectomy, or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for the past 12 or more months are still considered to be of childbearing potential, if the amenorrhea is possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression. Postmenopausal women (defined as women who have been amenorrheic for at least 12 consecutive months, in the appropriate age group, without other known or suspected primary cause) or women who have been sterilized surgically or who are otherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy with surgery at least 4 weeks prior to randomization) are not considered WOCBP. Subjects who have undergone tubal ligation are NOT considered as surgically sterile.
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 IP. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (Medroxyprogesterone acetate- stabilized for at least 3 months); vaginal contraceptive; contraceptive implant; double barrier methods (e.g. condom and spermicide); Nuvaring vaginal hormonal birth control, IUD, or abstinence with a second method of birth control should the subject become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control.
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). Please see acceptable forms for "Female" birth control above. Abstinence is an acceptable method of birth control for males.
Study subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required scheduled study visits.
Study subjects must be willing to refrain from using any other treatments for Chronic Open Angle Glaucoma (COAG), other than the investigational product.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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973 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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