Apioc Presbyopic Contact Lens
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Presbyopia
- Refractive Errors
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 40 years and 70 years
- Gender
- Both males and females
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 thi...
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.
Tracking Information
- NCT #
- NCT04437732
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Thomas G Quinn, OD, MS, FAAO Drs. Quinn, Foster & Associates Principal Investigator: Jason R Miller, OD, MBA Eyecare Professionals of Powell
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