Apioc Contact Lens Feasibility

Lentechs, LLC50 enrolled

Overview

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.

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

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Ametropia Myopia Hyperopia Astigmatism Presbyopia

Interventions

Apioc Contact Lens DesignDEVICE

Novel soft contact lens design.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Vertical Movement of Contact Lens in Downgaze

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

Time frame: After 15 minutes of on-eye settling

Secondary Outcomes

Movement of contact lens with blink

Movement of contact lens in straight-ahead gaze with a blink in millimeters.

Time frame: 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.

Time frame: 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.

Time frame: After 15 minutes of on-eye settling

Data from ClinicalTrials.gov

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