NCT03688672

Apioc Contact Lens Feasibility

Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Lentechs, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ametropia
• Myopia
• Hyperopia
• Astigmatism
• Presbyopia

Interventions

Type	Name	Description
DEVICE	Apioc Contact Lens Design	Novel soft contact lens design.

Timeline

• Start date: 2018-10-01
• Primary completion: 2020-10-31
• Completion: 2020-10-31
• First posted: 2018-09-28
• Last updated: 2022-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study