Ametropia, Astigmatism, Hyperopia, Myopia, Presbyopia
Conditions
Keywords
contact lens, soft contact lens, feasibility
Brief summary
This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.
Detailed description
This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the Apioc Contact Lens design will yield a successful fit across subjects. We will also determine the percentage of subjects who can be successfully fitted with the Apioc Contact Lens Design. Because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. The data will be collected in a single visit for most subjects. A few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. The key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. Subjects will only wear contact lenses while in the office.
Interventions
DEVICEApioc Contact Lens Design
Novel soft contact lens design.
Sponsors
Lentechs, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Thirty subjects will be at least 40 years of age and no more than 60 years of age. Ten subjects will be at least 18 years of age and no more than 29 years of age. Ten subjects will be at least 30 years of age and no more than 39 years of age. 2. The subject must have ≤ 1.50 D of corneal astigmatism. 3. The subject should have clear, healthy corneas. 4. The subject should have a normal, healthy conjunctiva in both eyes. 5. The subject should be free of active ocular disease. Refractive error and presbyopia are permitted. 6. The subject must provide written informed consent. 7. The subject must appear willing and able to adhere to the instructions set forth in this protocol.
Exclusion criteria
1. No irregular corneal astigmatism is permitted. 2. No pterygia or corneal scarring that would interfere with contact lens wear. 3. No pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear. 4. The subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vertical Movement of Contact Lens in Downgaze | After 15 minutes of on-eye settling | Vertical movement of the contact lens relative to the eye in downgaze in millimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement of contact lens with blink | After 15 minutes of on-eye settling | Movement of contact lens in straight-ahead gaze with a blink in millimeters. |
| Visual Acuity | After 15 minutes of on-eye settling | logMAR visual acuity at 40 cm through the contact lens with distance correction in trial frame over the Apioc contact lens. |
| Comfort questionnaire | After 15 minutes of on-eye settling | Subjects will be asked to assess the comfort of each lens by marking an X on a line between 0 and 100. |
Countries
United States
Outcome results
None listed