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Apioc Contact Lens Feasibility

Primary Purpose

Ametropia, Myopia, Hyperopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apioc Contact Lens Design
Sponsored by
Lentechs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Ametropia focused on measuring contact lens, soft contact lens, feasibility

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Apioc Lens

Arm Description

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

Outcomes

Primary Outcome Measures

Vertical Movement of Contact Lens in Downgaze
Vertical movement of the contact lens relative to the eye in downgaze in millimeters.

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2018
Last Updated
January 17, 2022
Sponsor
Lentechs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03688672
Brief Title
Apioc Contact Lens Feasibility
Official Title
Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lentechs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ametropia, Myopia, Hyperopia, Astigmatism, Presbyopia
Keywords
contact lens, soft contact lens, feasibility

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apioc Lens
Arm Type
Other
Arm Description
All subjects will wear the same, Apioc Contact Lens design.
Intervention Type
Device
Intervention Name(s)
Apioc Contact Lens Design
Intervention Description
Novel soft contact lens design.
Primary Outcome Measure Information:
Title
Vertical Movement of Contact Lens in Downgaze
Description
Vertical movement of the contact lens relative to the eye in downgaze in millimeters.
Time Frame
After 15 minutes of on-eye settling
Secondary Outcome Measure Information:
Title
Movement of contact lens with blink
Description
Movement of contact lens in straight-ahead gaze with a blink in millimeters.
Time Frame
After 15 minutes of on-eye settling
Title
Visual Acuity
Description
logMAR visual acuity at 40 cm through the contact lens with distance correction in trial frame over the Apioc contact lens.
Time Frame
After 15 minutes of on-eye settling
Title
Comfort questionnaire
Description
Subjects will be asked to assess the comfort of each lens by marking an "X" on a line between 0 and 100.
Time Frame
After 15 minutes of on-eye settling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Wagner, OD, MS
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Apioc Contact Lens Feasibility

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