Bioequivalence Study With Clinical Endpoint Comparing Brinzolamide 1% Ophthalmic Suspension to Azopt® 1% Ophthalmic Suspension In the Treatment of Chronic Open Angle Glaucoma or Ocular Hypertension in Both Eyes
Condition: Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Test-Brinzolamide 1% Ophthalmic suspension; Reference-Brinzolamide 1% Ophthalmic suspension
Intervention MeSH terms: Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 973.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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.

          3. 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.

          4. 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.

          5. Baseline best corrected visual acuity equivalent to 20/200 or better in each eye.

          6. 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.

          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.

             *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.

         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 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.

         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). Please see acceptable forms for "Female" birth control
             above. Abstinence is an acceptable method of birth control for males.

         12. 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.

         13. 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:

          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 defined as 325mg taken on three consecutive days.

         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/disc ratio greater than 0.8, split fixation, or functionally significant
             (in the investigators' 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 20 cigarettes or any other
             equivalent tobacco product/day)

         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. Subjects who are in the investigator's best judgment at risk of visual field or visual
             acuity worsening as a consequence of participation of trial.

         26. Chronic use of any systemic medication that may affect IOP with less than three 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.)

         27. Use of any prescribed medication during last two weeks or Over the Counter (OTC)
             medicinal products during the last one week preceding the first dosing that is
             affecting the IOP or result in drug-drug interaction with the study drug.

         28. Major illness, as per investigator discretion, during 3 months before screening

         29. Subjects who are employees of site or Clinical research organization (CRO) or sponsor
             or immediate family of employees

         30. Participating in a clinical study within the past 3 months.