Presbyopia Eye Diseases Presbyopia
Conditions
Interventions
Prospective crossover single-center feasibility study of two presbyopia-correcting contact lens systems. Up to 130 subjects will be randomized. Each subject will wear one Test Lens System (AIROPTIX AQ
Sponsors
Verily Life Sciences LLC (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy and competent, as determined by the Investigator 2. At least 50 years of age 3. Able to read and speak English 4. Able and willing to sign written Informed Consent Form 5. Must be a current or former contact lens wearer 6. Must have at least 20/25 distance and near vision in each eye best corrected 7. Must use a presbyopic reading correction of at least +2.25 diopters 8. Must have < or = 1.00D astigmatism
Exclusion criteria
Exclusion criteria: 1. Eye injury within 12 weeks immediately prior to enrollment for this study 2. Anterior segment infection, inflammation, abnormality or any other anterior segment ocular disease that contraindicates contact lens wear as determined by the Investigator 3. Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator 4. History of herpetic keratitis 5. History of refractive surgery or irregular cornea 6. History of multifocal or monovision intraocular lens replacement surgery 7. > 1.0mm anisocoria 8. Slit lamp findings (at baseline) that are more severe than mild findings (greater than grade 2) 9. Corneal vascularization greater than 1 mm of penetration 10. A clinically significant dry eye determined by the Investigator 11. Participation of the subject in a clinical contact lens study (including contact lens or contact lens care product) within the previous 30 days 12. The Investigator, family members of the Investigator, family members of the Investigator's staff, or individuals living in the households of the aforementioned persons 13. Any additional condition or situation that, in the opinion of the Investigator, makes the subject inappropriate for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. High-contrast near visual acuity (HC-NVA) 2. Low-contrast intermediate visual acuity (LC-IVA) Measured at both the visit when the test contact lens system is being worn and the visit when the control contact lens system is being worn. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Low-contrast near visual acuity (LC-NVA) and stereopsis 2. The safety endpoints are biomicroscopy findings and adverse events Measured at both the visit when the test contact lens system is being worn and the visit when the control contact lens system is being worn. | — |
Countries
United Kingdom
Contacts
Public ContactTrisha Patel
Outcome results
None listed