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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apioc Lens | Other | All subjects will wear the same, Apioc Contact Lens design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apioc Contact Lens Design | Device | Novel soft contact lens design. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vertical Movement of Contact Lens in Downgaze | Vertical movement of the contact lens relative to the eye in downgaze in millimeters. | After 15 minutes of on-eye settling |
| Measure | Description | Time Frame |
|---|---|---|
| Movement of contact lens with blink | Movement of contact lens in straight-ahead gaze with a blink in millimeters. | After 15 minutes of on-eye settling |
| Visual Acuity | logMAR visual acuity at 40 cm through the contact lens with distance correction in trial frame over the Apioc contact lens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Wagner, OD, MS | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43230 | United States |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| After 15 minutes of on-eye settling |
| Comfort questionnaire | Subjects will be asked to assess the comfort of each lens by marking an "X" on a line between 0 and 100. | After 15 minutes of on-eye settling |