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

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.

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.