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

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 eyeson stable ocular hypotensive treatment regimen.

2. Subjects requiring treatment of both eyes and are able to discontinue use of allocular hypotensive medication(s) or switch ocular hypotensive medications and undergoappropriate washout period.

3. Adequate wash-out period prior to baseline of any ocular hypotensive medication. Inorder to minimize potential risk to subjects due to IOP elevations during the washoutperiod, investigator may choose to substitute a parasympathomimetic or carbonicanhydrase inhibitor in place of a sympathomimetic, alpha-agonist, beta-adrenergicblocking agent, or prostaglandins. However, subjects must have discontinued all ocularhypotensive 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 ofIOP 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 thelatest version of the IRB informed consent form. In addition, study subjects must signa Health Insurance Portability and Accountability Act (HIPAA) authorization, ifapplicable.

7. Study subjects should be literate and willing to complete the subject diary regularlyas directed.

8. Study subjects must be in good health and free from any clinically significant diseaseapart from indication under study.

9. Females of child bearing potential (WOCBP*) must not be pregnant or lactating atbaseline visit (as documented by a negative serum pregnancy test with a minimumsensitivity 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 theyare postmenopausal. Female subjects of childbearing potential (WOCBP) are defined assexually mature women without prior hysterectomy, or who have had any evidence ofmenses in the past 12 months. However, women who have been amenorrheic for the past 12or more months are still considered to be of childbearing potential, if the amenorrheais possibly due to other causes, including prior chemotherapy, anti-estrogens, orovarian suppression. Postmenopausal women (defined as women who have been amenorrheicfor at least 12 consecutive months, in the appropriate age group, without other knownor suspected primary cause) or women who have been sterilized surgically or who areotherwise proven sterile (i.e., total hysterectomy, or bilateral oophorectomy withsurgery at least 4 weeks prior to randomization) are not considered WOCBP. Subjectswho have undergone tubal ligation are NOT considered as surgically sterile.

10. Female subjects of childbearing potential must be willing to use an acceptable form ofbirth control from the day of the first dose administration to 30 days after the lastadministration of IP. For the purpose of this study the following are consideredacceptable methods of birth control: oral or injectable contraceptives, contraceptivepatches, Depo-Provera® (Medroxyprogesterone acetate- stabilized for at least 3months); vaginal contraceptive; contraceptive implant; double barrier methods (e.g.condom and spermicide); Nuvaring vaginal hormonal birth control, IUD, or abstinencewith a second method of birth control should the subject become sexually active. Asterile 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 theirpartners, from the day of the first dose administration (to 30 days after the lastadministration of study drug). Please see acceptable forms for "Female" birth controlabove. Abstinence is an acceptable method of birth control for males.

12. Study subjects must be willing and able to understand and comply with the requirementsof the protocol, including attendance at the required scheduled study visits.

13. Study subjects must be willing to refrain from using any other treatments for ChronicOpen Angle Glaucoma (COAG), other than the investigational product.

Exclusion Criteria:

1. Females who are pregnant, breast feeding, or planning a pregnancy during the course ofthe study and for 30 days after last study dose.

2. Females of childbearing potential who do not agree to utilize an adequate form ofcontraception.

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 theGoldmann applanation tonometer e.g. corneal dystrophy, corneal abrasions, cornealulcers, keratitis, keratoconus and keratoglobus.

6. Functionally significant visual field loss

7. Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity toany 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-dosesalicylate therapy defined as 325mg taken on three consecutive days.

12. Use within six months prior to baseline of intravitreal or subtenon injection ofophthalmic 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, filteringsurgery or laser surgery for IOP reduction

15. Amblyopia - only one sighted eye

16. Severe retinal disease or other severe ocular pathology, such as glaucomatous damagewith 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 otherequivalent 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 bloodpressure less than 60 mm Hg or more than 90 mm Hg and Pulse rate less than 50beats/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 onlaboratory testing

25. Subjects who are in the investigator's best judgment at risk of visual field or visualacuity worsening as a consequence of participation of trial.

26. Chronic use of any systemic medication that may affect IOP with less than three monthstable 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 isaffecting 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 sponsoror immediate family of employees

30. Participating in a clinical study within the past 3 months.