Apioc Presbyopic Contact Lens

NCT04437732 | Completed FDA Device

• 1 other identifier: LEN-002
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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).

Conditions

Presbyopia; Refractive Errors

Keywords

contact lens; soft contact lens

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  LogMAR visual acuity

  30 days

Secondary Outcomes (1)

• Comfort

  30 days

Study Arms (1)

Apioc Lens

OTHER

All subjects will wear either the Apioc-P or Apioc-PT contact lens design

Device: Apioc-P and Apioc-PT Contact Lens Design

Interventions

Apioc-P and Apioc-PT Contact Lens Design DEVICE

Novel soft contact lens design

Apioc Lens

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lentechs, LLC: lead

Study Sites (2)

Quinn Foster & Associates

Athens, Ohio, 45701, United States

Location

EyeCare Professionals of Powell

Powell, Ohio, 43065, United States

Location

MeSH Terms

Conditions

Presbyopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Thomas G Quinn, OD, MS, FAAO

  Drs. Quinn, Foster & Associates

  PRINCIPAL INVESTIGATOR

• Jason R Miller, OD, MBA

  Eyecare Professionals of Powell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: November 11, 2019
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)