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 glaucoma or prior diagnosis of POAG suspect including OHTN in at least one eye for whom no 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 focal thinning of neuroretinal rim or nerve fiber layer defects or a difference in cup/disc ratio \> 0.2, not explained by anisometropia or other non-glaucomatous causes (2) visual field defects consistent with optic nerve cupping, with glaucomatous hemifield test outside normal limits or a pattern standard deviation (PSD) worse than 5th percentile (P\<0.05) by Standard Automated Perimetry, or VF defects with Goldmann visual field test consistent with glaucomatous nerve fiber layer loss including paracentral scotoma, nasal step or arcuate defects
• •* Diagnosis of POAG suspect from medical records established by open angles and IOP ≥22 mmHg (OHTN) OR abnormal appearing optic disc appearance OR glaucomatous 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 in both eyes.
• •4. Mean keratometry value is between 7.5 mm and 8.2 mm in at least one eye (the miLens eye)
• •5. GEN4 miLens contact lens fitting on the subject's eye is acceptable by a slit lamp exam at Day 0 (measurement study visit)
• •6. Subjects with ability to discontinue habitual IOP-lowering medications, if any, in both eyes on Day 0 visit until the end of the 24-hour wear period (and if applicable, similarly for the Week 1 visit) (No preservative-free topical glaucoma medications will be allowed for the duration of the study)
• •7. Able to understand, sign and complete the informed consent and available to complete the minimum set of self-acquired smartphone images over the 24-hour contact lens wear period, preferably at an assigned site and likely available for a repeat session after a week