Comparison of Latanoprost PPDS With Timolol Maleate GFS in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Inclusion Criteria:

1. Male or female, 18 years or older at the time of the screening examination

2. Subject diagnosed with bilateral OAG or OH

3. Subject IOP is currently controlled (< 21 mmHg) with a topical prostaglandin or in
conjunction with one other topical ocular hypotensive drug, not including any
fixed-combination formulations (i.e., Cosopt, Combigan, Azarga, etc.) for at least
one month or more

4. Subject who has lower and upper puncta > 0.5 mm and < 0.9 mm (pre-dilation) in both
eyes

5. Subject must be able and willing to read, comprehend and give Authorization for
Use/Disclosure of Health Information (HIPAA) and informed consent

6. Subject must be willing to comply with study instructions, dosing (if applicable),
agree to make all office appointments, and complete the entire course of the study

7. Women of child-bearing potential must not be pregnant or lactating, must have a
negative pregnancy test at screening and must be practicing an adequate method of
birth control, including intrauterine device (IUD); oral, dermal ("patch"), implant
or injected contraceptives; tubal ligation; or barrier methods with spermicide

8. Subject has a central corneal thickness of > 500 μm and < 600 μm in study eye

9. Subject has a BCVA or pinhole visual acuity (Snellen) of 20/100 or better in both
eyes

Exclusion Criteria:

1. Subject with a history of non-response to topical prostaglandin eye drops for OAG/OH

2. Subject with angle-closure glaucoma, neovascular glaucoma, traumatic glaucoma or
iridocorneal endothelium syndrome in either eye

3. Subject with a known sensitivity to latanoprost, timolol, fluorescein, topical
anesthetic, silicone, any inactive ingredient of the L-PPDS or any other products
required for the study procedures

4. Subject with a history of intolerance to topical beta-blocker therapy

5. Subject with > 0.8 vertical cup or completely notched optic nerve head rim in either
eye

6. Subject with any functionally significant visual field loss or progressive field loss
within the last year in either eye

7. Subject with a history of complications, AEs, trauma or disease in the nasolacrimal
area, whether or not it was due to punctal plug wear, including but not limited to
dacryocystitis, inflammation or canaliculitis in study eye

8. Subject with structural lid abnormalities (i.e., ectropion, entropion) in study eye

9. Subject with an active lid disease in either eye (i.e., moderate or severe
blepharitis, meibomianitis) that requires medical treatment

10. Subject with a history of chronic/recurrent inflammatory eye disease (i.e.,
scleritis, uveitis, herpes keratitis) in either eye

11. Subject who would require the use of any ocular topical medication(s), an over-the
counter drop(s), ointment(s) or gel(s), other than the study ocular hypotensive
medication(s) in either eye during the study period

12. Subject who has had any ophthalmic surgical procedures (i.e., glaucoma laser,
minimally invasive glaucoma surgery, cataract, refractive, etc.) in study eye within
the last six months or will require ophthalmic surgery before completing the study

13. Subject with a history of penetrating keratoplasty in study eye

14. Subject who is incapable of instilling ocular drops into his or her eyes

15. Subject requiring the use of a contact lens in either eye at any time during the
study period

16. Subject with advanced diabetic retinopathy, branch retinal vein occlusion or central
retinal vein occlusion in either eye

17. Subject with a history of macular edema in either eye

18. Subject currently on any systemic medication [i.e., beta-blocker, carbonic anhydrase
inhibitors, corticosteroids (including dermal), etc.], that may have an effect on the
subject's IOP, or who will require its use during the study period (Note: an inhaled
steroid, systemic beta-blocker or β-adrenoceptor antagonist may be permitted,
providing the subject has maintained a stable dosage regimen for at least the last
three months)

19. Subject contraindicated to therapy with a beta-blocker (i.e., history or presence of
bradycardia, untreated congestive heart failure, untreated second- or third-degree
heart block, sino-atrial block, myasthenia gravis, cardiogenic shock, history or
presence of bronchial asthma, bronchial hyperreactivity, severe chronic obstructive
pulmonary disease, or history of bronchospasm)

20. Subject with an uncontrolled systemic disease or a medical condition that may
increase the risk associated with study participation or administration of study
treatment or that may interfere with the interpretation of study results (e.g.,
autoimmune disease if the subject is on chronic medications and has ocular
involvement; host-versus-graft disease)

21. Subject currently participating or has participated within the last 30 days prior to
the start of this study in a drug, device or other investigational research study