Apioc Contact Lens Feasibility

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688672
• Other study ID #: LEN001
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: January 2022
• Source: Lentechs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ametropia
• Astigmatism
• Hyperopia
• Myopia
• Presbyopia
• Refractive Errors

Intervention

Device:
• Apioc Contact Lens Design
Novel soft contact lens design.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Lentechs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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