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Apioc Toric/Spherical Single Vision Contact Lens

Primary Purpose

Refractive Errors

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Apioc-A and Apioc-S Contact Lenses

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring contact lens, soft contact lens

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

The subject must provide written informed consent.
The subject must appear willing and able to adhere to the instructions set forth in this protocol.
At least 18 years of age and no more than 35 years of age.
≤ 4.00 D of corneal astigmatism.
≤ 4.00 D of refractive astigmatism.
Refractive error range +20.00 DS to -20.00 DS
Flat and steep keratometry readings within 40 to 50D.
Clear, healthy corneas with no irregular astigmatism.
Normal, healthy conjunctiva in both eyes.
Free of active ocular disease. Refractive error is permitted.
Be a current or former (within the last 12 months) contact lens wearer.
Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria:

Irregular corneal astigmatism.
Presbyopia
Corneal scarring unless off line-of-site and well healed.
Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
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.
Systemic disease that would interfere with contact lens wear.
Currently pregnant or lactating (by self-report).
History of strabismus or eye movement disorder.
Active allergies that may inhibit contact lens wear.
Upper eyelid margin at or above the superior limbus.
History of ocular or lid surgery.

Sites / Locations

Quinn Foster & Associates
EyeCare Professionals of Powell

Outcomes

Primary Outcome Measures

Visual Acuity

LogMAR distance visual acuity

Secondary Outcome Measures

Comfort

Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).

Rotational Stability of Apioc-A

Clockwise or counter-clockwise rotation

Full Information

NCT ID

NCT03970512

First Posted

May 29, 2019

Last Updated

January 17, 2022

Sponsor

Lentechs, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03970512

Brief Title

Apioc Toric/Spherical Single Vision Contact Lens

Official Title

30 Day Fitting of a New Toric Contact Lens

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

May 31, 2019 (Actual)

Primary Completion Date

March 18, 2021 (Actual)

Study Completion Date

March 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lentechs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractive Errors

Keywords

contact lens, soft contact lens

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Apioc-A and Apioc-S Contact Lenses

Intervention Description

Appropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days.

Primary Outcome Measure Information:

Title

Visual Acuity

Description

LogMAR distance visual acuity

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Comfort

Description

Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).

Time Frame

30 days

Title

Rotational Stability of Apioc-A

Description

Clockwise or counter-clockwise rotation

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject must provide written informed consent. The subject must appear willing and able to adhere to the instructions set forth in this protocol. At least 18 years of age and no more than 35 years of age. ≤ 4.00 D of corneal astigmatism. ≤ 4.00 D of refractive astigmatism. Refractive error range +20.00 DS to -20.00 DS Flat and steep keratometry readings within 40 to 50D. Clear, healthy corneas with no irregular astigmatism. Normal, healthy conjunctiva in both eyes. Free of active ocular disease. Refractive error is permitted. Be a current or former (within the last 12 months) contact lens wearer. Best-corrected near and distance visual acuity better than or equal to 20/25. Exclusion Criteria: Irregular corneal astigmatism. Presbyopia Corneal scarring unless off line-of-site and well healed. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear. 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. Systemic disease that would interfere with contact lens wear. Currently pregnant or lactating (by self-report). History of strabismus or eye movement disorder. Active allergies that may inhibit contact lens wear. Upper eyelid margin at or above the superior limbus. History of ocular or lid surgery.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas G Quinn, OD, MS, FAAO

Organizational Affiliation

Drs. Quinn, Foster & Associates

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jason R Miller, OD, MBA

Organizational Affiliation

Eyecare Professionals of Powell

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quinn Foster & Associates

City

Athens

State/Province

Ohio

ZIP/Postal Code

45701

Country

United States

Facility Name

EyeCare Professionals of Powell

City

Powell

State/Province

Ohio

ZIP/Postal Code

43065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Apioc Toric/Spherical Single Vision Contact Lens

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