Apioc Contact Lens Feasibility

NCT03688672 | Completed FDA Device

• 1 other identifier: LEN001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.

Conditions

Ametropia; Myopia; Hyperopia; Astigmatism; Presbyopia

Keywords

contact lens; soft contact lens; feasibility

Outcome Measures

Primary Outcomes (1)

• Vertical Movement of Contact Lens in Downgaze

  Vertical movement of the contact lens relative to the eye in downgaze in millimeters.

  After 15 minutes of on-eye settling

Secondary Outcomes (3)

• Movement of contact lens with blink

  After 15 minutes of on-eye settling

• Visual Acuity

  After 15 minutes of on-eye settling

• Comfort questionnaire

  After 15 minutes of on-eye settling

Study Arms (1)

Apioc Lens

OTHER

All subjects will wear the same, Apioc Contact Lens design.

Device: Apioc Contact Lens Design

Interventions

Apioc Contact Lens Design DEVICE

Novel soft contact lens design.

Apioc Lens

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Thirty subjects will be at least 40 years of age and no more than 60 years of age. Ten subjects will be at least 18 years of age and no more than 29 years of age. Ten subjects will be at least 30 years of age and no more than 39 years of age.
• The subject must have ≤ 1.50 D of corneal astigmatism.
• The subject should have clear, healthy corneas.
• The subject should have a normal, healthy conjunctiva in both eyes.
• The subject should be free of active ocular disease. Refractive error and presbyopia are permitted.
• The subject must provide written informed consent.
• The subject must appear willing and able to adhere to the instructions set forth in this protocol.

You may not qualify if:

• No irregular corneal astigmatism is permitted.
• No pterygia or corneal scarring that would interfere with contact lens wear.
• No pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear.
• The subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.

Sponsors & Collaborators

• Lentechs, LLC: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43230, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia; Astigmatism; Presbyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Heidi Wagner, OD, MS

  Ohio State University

  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: September 25, 2018
• First Posted: September 28, 2018
• Study Start: October 1, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)