Apioc Contact Lens Feasibility

Sponsor

Lentechs, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03688672

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ametropia Myopia Hyperopia Astigmatism Presbyopia	Device: Apioc Contact Lens Design	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Vertical Movement of Contact Lens in Downgaze [After 15 minutes of on-eye settling]
Vertical movement of the contact lens relative to the eye in downgaze in millimeters.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.