NCT04437732

Apioc Presbyopic Contact Lens

30 Day Trial Fitting of a New Bifocal Contact Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Lentechs, LLC · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way you wear your current contact lenses for approximately one month (no more than 35 days).

Detailed description

Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved by the U.S. Food and Drug Administration (FDA), although the contact lens material, called Definitive 74, is already approved and marketed for contact lenses that are similar to Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact lens the way they wear their current contact lenses for approximately one month (no more than 35 days). Participation in this study will include a minimum of four study visits. The first will last up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45 minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be fitting properly at the second visit, then another lens will be ordered for participants and they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects will participate in this study.

Conditions

• Presbyopia
• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Apioc-P and Apioc-PT Contact Lens Design	Novel soft contact lens design

Timeline

• Start date: 2019-11-11
• Primary completion: 2021-06-09
• Completion: 2021-06-09
• First posted: 2020-06-18
• Last updated: 2022-01-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study