Apioc Contact Lens Feasibility

NCT ID: NCT03688672

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-10-31

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.

Conditions

Ametropia; Myopia; Hyperopia; Astigmatism; Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Apioc Lens

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

Group Type: OTHER

Apioc Contact Lens Design

Intervention Type: DEVICE

Novel soft contact lens design.

Interventions

Apioc Contact Lens Design

Novel soft contact lens design.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lentechs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi Wagner, OD, MS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

LEN001

Identifier Type: -

Identifier Source: org_study_id