Apioc Toric/Spherical Single Vision Contact Lens

Refractive Errors Clinical Trial

Official title:

30 Day Fitting of a New Toric Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970512
• Other study ID #: LEN004
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: March 18, 2021

Study information

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

Clinical Trial Summary

The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. The subject must provide written informed consent.

2. The subject must appear willing and able to adhere to the instructions set forth in this protocol.

3. At least 18 years of age and no more than 35 years of age.

4. = 4.00 D of corneal astigmatism.

5. = 4.00 D of refractive astigmatism.

6. Refractive error range +20.00 DS to -20.00 DS

7. Flat and steep keratometry readings within 40 to 50D.

8. Clear, healthy corneas with no irregular astigmatism.

9. Normal, healthy conjunctiva in both eyes.

10. Free of active ocular disease. Refractive error is permitted.

11. Be a current or former (within the last 12 months) contact lens wearer.

12. Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria:

1. Irregular corneal astigmatism.

2. Presbyopia

3. Corneal scarring unless off line-of-site and well healed.

4. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.

5. Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted.

6. Systemic disease that would interfere with contact lens wear.

7. Currently pregnant or lactating (by self-report).

8. History of strabismus or eye movement disorder.

9. Active allergies that may inhibit contact lens wear.

10. Upper eyelid margin at or above the superior limbus.

11. History of ocular or lid surgery.

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Apioc-A and Apioc-S Contact Lenses
Appropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days.

Locations

Country	Name	City	State
United States	Quinn Foster & Associates	Athens	Ohio
United States	EyeCare Professionals of Powell	Powell	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	Visual Acuity	LogMAR distance visual acuity	30 days
Secondary	Comfort	Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).	30 days
Secondary	Rotational Stability of Apioc-A	Clockwise or counter-clockwise rotation	30 days