24-hour Wear Performance and Safety Study of Smartlens miLens Contact Lens for IOP Monitoring

Inclusion Criteria:

1. Subjects ≥22 to ≤80 years of age

2. Subjects with:

• prior diagnosis of POAG in at least one eye, including normal tension glaucomaor prior diagnosis of POAG suspect including OHTN in at least one eye for whomno evidence or suspicion of structural or functional glaucomatous damage exists

• Diagnosis of POAG from medical records characterized by open angles and (1) optic nerve cupping consistent with glaucoma, with diffuse or focalthinning of neuroretinal rim or nerve fiber layer defects or a differencein cup/disc ratio > 0.2, not explained by anisometropia or othernon-glaucomatous causes (2) visual field defects consistent with opticnerve cupping, with glaucomatous hemifield test outside normal limits or apattern standard deviation (PSD) worse than 5th percentile (P<0.05) byStandard Automated Perimetry, or VF defects with Goldmann visual fieldtest consistent with glaucomatous nerve fiber layer loss includingparacentral scotoma, nasal step or arcuate defects

• Diagnosis of POAG suspect from medical records established by open anglesand IOP ≥22 mmHg (OHTN) OR abnormal appearing optic disc appearance ORglaucomatous visual field defects

• no prior history of POAG/OHTN in either eye

3. In subjects with no history of POAG/OHTN, GAT IOP difference between eyes must be ≤ 2 mmHg, with IOP no less than 10 mmHg in both eyes and no greater than 21 mmHg inboth eyes.

4. Mean keratometry value is between 7.5 mm and 8.2 mm in at least one eye (the miLenseye)

5. GEN4 miLens contact lens fitting on the subject's eye is acceptable by a slit lampexam at Day 0 (measurement study visit)

6. Subjects with ability to discontinue habitual IOP-lowering medications, if any, inboth eyes on Day 0 visit until the end of the 24-hour wear period (and ifapplicable, similarly for the Week 1 visit) (No preservative-free topical glaucomamedications will be allowed for the duration of the study)

7. Able to understand, sign and complete the informed consent and available to completethe minimum set of self-acquired smartphone images over the 24-hour contact lenswear period, preferably at an assigned site and likely available for a repeatsession after a week

Exclusion Criteria:

1. BCVA worse than 20/200 in either eye

2. Greater than 6 diopters spherical equivalent in either eye

3. Greater than 3 diopters of keratometric cylinder in either eye

4. Central corneal thickness greater than 0.60 mm or less than 0.50 mm in either eye (per GAT study guidelines in ANSI Z80.10)

5. Known history of difficulty in obtaining Goldmann IOP measurements or any factorsthat might contribute to inaccurate Goldmann IOP measurements (e.g. lid squeezing ortremor)

6. Subjects who have had ocular surgery within the last 6 months in either eye

7. Subjects who have had corneal refractive surgery

8. History of Keratoconus, corneal scarring, or other chronic corneal disease in eithereye

9. Subjects with contraindication for wearing contact lenses or history of intoleranceor difficulties associated with contact lens use including history of dry eyedisease

10. Subjects with current signs/symptoms of clinically significant dry eye disease

11. Active eye disease, injury or ocular abnormalities affecting the cornea,conjunctiva, or eyelids or slit lamp findings ≥ grade 3

12. Active inflammation of either eye

13. Active infection of either eye

14. Corneal vascularization of either eye

15. Known allergy to silicone

16. Known allergy to corneal anesthetic

17. Secondary forms of open angle glaucoma (OAG) in either eye

18. Poor or eccentric fixation in either eye

19. Nystagmus

20. Microphthalmos of either eye

21. Buphthalmos of either eye

22. Subject is pregnant, lactating or planning to become pregnant during the course ofthe study

23. Concurrent participation in any clinical trial

24. Disabling arthritis or limited motor coordination that might limit self-handling ofa smart phone with miLens eyepiece attached.

25. Experience using or interacting with miLens and smartphone imaging app during aprevious usability or clinical trial

26. Any affiliation with Smartlens and its employees

27. Subjects with any significant dermatologic condition (e.g., history of skinirritation, allergies, skin eczema) that poses a concern for skin contact with thecamera eyepiece, based on the Investigator's judgment