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OpenTrials
Completed

NCT Number: NCT03970512

Apioc Toric/Spherical Single Vision Contact Lens

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quinn Foster & Associates, Athens, Ohio, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apioc-A and Apioc-S Contact Lenses

Device

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

Primary outcomes

  1. Visual Acuity

    Time frame: 30 days

    LogMAR distance visual acuity

Secondary outcomes

  1. Comfort

    Time frame: 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

    Time frame: 30 days

    Clockwise or counter-clockwise rotation

Sponsors and collaborators

Lead sponsor

Lentechs, LLC

Industry

Registry information

Official study title

30 Day Fitting of a New Toric Contact Lens

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 31, 2019
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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