APIOC Sphere and APIOC Astigmatism

Sponsor
Lentechs, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04806802
Collaborator
(none)
50
6
1
7.5
8.3
1.1

Study Details

Study Description

Brief Summary

Vision and comfort, both objective and subjective, will be assessed for single vision contact lens wearers for either the APIOC™ Sphere or the APIOC™ Astigmatism contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: APIOC Sphere and APIOC Astigmatism
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
7 Day Trial of APIOC Sphere and APIOC Astigmatism
Actual Study Start Date :
Mar 18, 2021
Actual Primary Completion Date :
Oct 31, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: APIOC Sphere or Astigmatism

Single Vision Spherical or Toric Contact Lens

Device: APIOC Sphere and APIOC Astigmatism
Single Vision Contact Lenses

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity [Day 7]

    High and Low Contrast LogMAR, Distance

  2. Subjective Vision Quality [Day 7]

    Visual analogue scale

  3. Comfort [Day 7]

    Visual analogue scale

Secondary Outcome Measures

  1. Subjective comfort [Day 7]

    Compared to habitual lenses

  2. Subjective vision [Day 7]

    Compared to habitual lenses

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 (diopters) of corneal astigmatism.

  5. ≤ 2.50 D of refractive astigmatism.

  6. Refractive error range +4.00 DS to -6.00 DS (diopters sphere)

  7. Flat and steep keratometry readings within 40 to 48 D.

  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, including exophoria at near that is 4 D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.

  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.

  12. Immediate family members or significant others of doctors or staff at the clinical site.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Complete Family Vision Care San Diego California United States 92123
2 Eola Eyes Orlando Florida United States 32803
3 Gaddie Eye Centers Lexington Kentucky United States 40517
4 Miamisburg Vision Care Miamisburg Ohio United States 45342
5 Vision Professionals New Albany Ohio United States 43054
6 Eyecare Professionals of Powell Powell Ohio United States 43065

Sponsors and Collaborators

  • Lentechs, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lentechs, LLC
ClinicalTrials.gov Identifier:
NCT04806802
Other Study ID Numbers:
  • LEN102
First Posted:
Mar 19, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022