Apioc Toric/Spherical Single Vision Contact Lens

NCT ID: NCT03970512

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2021-03-18

Brief 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.

Conditions

Refractive Errors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lentechs, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas G Quinn, OD, MS, FAAO

Role: PRINCIPAL_INVESTIGATOR

Drs. Quinn, Foster & Associates

Jason R Miller, OD, MBA

Role: PRINCIPAL_INVESTIGATOR

Eyecare Professionals of Powell

Locations

Quinn Foster & Associates

Athens, Ohio, United States

EyeCare Professionals of Powell

Powell, Ohio, United States

Countries

United States

Other Identifiers

LEN004

Identifier Type: -

Identifier Source: org_study_id