Apioc Toric/Spherical Single Vision Contact Lens

Sponsor
Lentechs, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03970512
Collaborator
(none)
51
2
21.6
25.5
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Apioc-A and Apioc-S Contact Lenses
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
30 Day Fitting of a New Toric Contact Lens
Actual Study Start Date :
May 31, 2019
Actual Primary Completion Date :
Mar 18, 2021
Actual Study Completion Date :
Mar 18, 2021

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [30 days]

    LogMAR distance visual acuity

Secondary Outcome Measures

  1. Comfort [30 days]

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

  2. Rotational Stability of Apioc-A [30 days]

    Clockwise or counter-clockwise rotation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quinn Foster & Associates Athens Ohio United States 45701
2 EyeCare Professionals of Powell Powell Ohio United States 43065

Sponsors and Collaborators

  • Lentechs, LLC

Investigators

  • Principal Investigator: Thomas G Quinn, OD, MS, FAAO, Drs. Quinn, Foster & Associates
  • Principal Investigator: Jason R Miller, OD, MBA, Eyecare Professionals of Powell

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lentechs, LLC
ClinicalTrials.gov Identifier:
NCT03970512
Other Study ID Numbers:
  • LEN004
First Posted:
May 31, 2019
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Lentechs, LLC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022