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

Prior treatment

• Subjects who have had ocular surgery within the last 6 months in either eye
• Subjects who have had corneal refractive surgery
• Concurrent participation in any clinical trial
• Experience using or interacting with miLens and smartphone imaging app during a previous usability or clinical trial

Other illness

• Known history of difficulty in obtaining Goldmann IOP measurements or any factors that might contribute to inaccurate Goldmann IOP measurements (e.g. lid squeezing or tremor)
• History of Keratoconus, corneal scarring, or other chronic corneal disease in either eye
• Subjects with contraindication for wearing contact lenses or history of intolerance or difficulties associated with contact lens use including history of dry eye disease
• Subjects with current signs/symptoms of clinically significant dry eye disease
• Active eye disease, injury or ocular abnormalities affecting the cornea, conjunctiva, or eyelids or slit lamp findings ≥ grade 3
• Active infection of either eye
• Known allergy to silicone
• Known allergy to corneal anesthetic
• Subjects with any significant dermatologic condition (e.g., history of skin irritation, allergies, skin eczema) that poses a concern for skin contact with the camera eyepiece, based on the Investigator's judgment

Other

• BCVA worse than 20/200 in either eye
• Greater than 6 diopters spherical equivalent in either eye
• Greater than 3 diopters of keratometric cylinder in either eye
• 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)
• Active inflammation of either eye
• Corneal vascularization of either eye
• Secondary forms of open angle glaucoma (OAG) in either eye
• Poor or eccentric fixation in either eye
• Nystagmus
• Microphthalmos of either eye
• Buphthalmos of either eye
• Subject is pregnant, lactating or planning to become pregnant during the course of the study
• Disabling arthritis or limited motor coordination that might limit self-handling of a smart phone with miLens eyepiece attached.
• Any affiliation with Smartlens and its employees

• Subjects ≥22 to ≤80 years of age
• 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
• 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.
• Mean keratometry value is between 7.5 mm and 8.2 mm in at least one eye (the miLens eye)
• GEN4 miLens contact lens fitting on the subject's eye is acceptable by a slit lamp exam at Day 0 (measurement study visit)
• 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)
• 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