Apioc Toric/Spherical Single Vision Contact Lens

NCT03970512 | Completed FDA Device

• 1 other identifier: LEN004
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.

Conditions

Refractive Errors

Keywords

contact lens; soft contact lens

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  LogMAR distance visual acuity

  30 days

Secondary Outcomes (2)

• Comfort

  30 days

• Rotational Stability of Apioc-A

  30 days

Interventions

Apioc-A and Apioc-S Contact Lenses DEVICE

Appropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 18 years of age and no more than 35 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
• Flat and steep 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 is 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.
• Presbyopia
• 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 drops 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.
• 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

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: May 31, 2019
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)