CClinicalTrials.gg
CompletedNCT03970512Updated Jan 19, 2022

Apioc Toric/Spherical Single Vision Contact Lens

An interventional study of Apioc-A and Apioc-S Contact Lenses in Refractive Errors, sponsored by Lentechs, LLC. Completed at 2 sites in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-19.

Sponsored by Lentechs, LLC · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Mar 2021, 5 years 6 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Non-randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Refractive Errors

Browse trials for

Keywords

  • contact lens
  • soft contact lens
03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 51 is below the median of 82 across 296 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Lentechs, LLC is the lead sponsor of 6 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
51 participants (actual)

Interventions

  • DeviceApioc-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.

06

What researchers measure

Primary outcomes

  1. Visual Acuity

    LogMAR distance visual acuity

    Time frame: 30 days

Secondary outcomes

  1. Comfort

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

    Time frame: 30 days

  2. Rotational Stability of Apioc-A

    Clockwise or counter-clockwise rotation

    Time frame: 30 days

07

Study locations

2 sites
  • Quinn Foster & Associates
    Athens, Ohio 45701, United States
  • EyeCare Professionals of Powell
    Powell, Ohio 43065, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03970512
Lead sponsor
Lentechs, LLC
Responsible party
Sponsor
First posted
May 31, 2019
Start date
May 31, 2019
Primary completion
Mar 18, 2021
Completion
Mar 18, 2021
Last update
Jan 19, 2022

Study contacts

Thomas G Quinn, OD, MS, FAAO
principal investigator · Drs. Quinn, Foster & Associates
Jason R Miller, OD, MBA
principal investigator · Eyecare Professionals of Powell

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion