Apioc Contact Lens Feasibility

Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism; Myopia; Hyperopia; Ametropia
• Intervention / Treatment: Device: Apioc Contact Lens Design

Detailed Description

This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the Apioc Contact Lens design will yield a successful fit across subjects. We will also determine the percentage of subjects who can be successfully fitted with the Apioc Contact Lens Design. Because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. The data will be collected in a single visit for most subjects. A few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. The key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. Subjects will only wear contact lenses while in the office.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43230
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
2. The subject must have ≤ 1.50 D of corneal astigmatism.
3. The subject should have clear, healthy corneas.
4. The subject should have a normal, healthy conjunctiva in both eyes.
5. The subject should be free of active ocular disease. Refractive error and presbyopia are permitted.
6. The subject must provide written informed consent.
7. The subject must appear willing and able to adhere to the instructions set forth in this protocol.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Apioc Lens; All subjects will wear the same, Apioc Contact Lens design.	Device: Apioc Contact Lens Design; Novel soft contact lens design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement of contact lens with blink	Movement of contact lens in straight-ahead gaze with a blink in millimeters.	After 15 minutes of on-eye settling
Visual Acuity	logMAR visual acuity at 40 cm through the contact lens with distance correction in trial frame over the Apioc contact lens.	After 15 minutes of on-eye settling
Comfort questionnaire	Subjects will be asked to assess the comfort of each lens by marking an "X" on a line between 0 and 100.	After 15 minutes of on-eye settling

Collaborators and Investigators

• Sponsor: Lentechs, LLC
• Investigators: Principal Investigator: Heidi Wagner, OD, MS, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: feasibility; soft contact lens; contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Astigmatism; Hyperopia
• Other Study ID Numbers: LEN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes