Status:
COMPLETED
Apioc Presbyopic Contact Lens
Lead Sponsor:
Lentechs, LLC
Conditions:
Presbyopia
Refractive Errors
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief 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, ...
Eligibility Criteria
Inclusion
- The subject must provide written informed consent.
- The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- At least 40 years of age and no more than 70 years of age.
- ≤ 4.00 D of corneal astigmatism.
- ≤ 4.00 D of refractive astigmatism.
- Refractive error range +20.00 DS to -20.00 DS
- Keratometry readings within 40 to 50D.
- Clear, healthy corneas with no irregular astigmatism.
- Normal, healthy conjunctiva in both eyes.
- Free of active ocular disease. Refractive error and presbyopia are permitted.
- Be a current or former (within the last 12 months) contact lens wearer.
- Best-corrected near and distance visual acuity better than or equal to 20/25.
Exclusion
- Irregular corneal astigmatism.
- Corneal scarring unless off line-of-site and well healed.
- Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 times per week is permitted.
- Systemic disease that would interfere with contact lens wear.
- Currently pregnant or lactating (by self-report).
- History of strabismus or eye movement disorder, including exophoria at near that is 4D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
- Active allergies that may inhibit contact lens wear.
- Upper eyelid margin at or above the superior limbus.
- History of ocular or lid surgery.
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04437732
Start Date
November 11 2019
End Date
June 9 2021
Last Update
January 19 2022
Active Locations (2)
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1
Quinn Foster & Associates
Athens, Ohio, United States, 45701
2
EyeCare Professionals of Powell
Powell, Ohio, United States, 43065