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OpenTrials
Completed

NCT Number: NCT04806802

APIOC Sphere and APIOC Astigmatism

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complete Family Vision Care, San Diego, California, United States

Loading trial locations.

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 (diopters) of corneal astigmatism.
  • ≤ 2.50 D of refractive astigmatism.
  • Refractive error range +4.00 DS to -6.00 DS (diopters sphere)
  • Flat and steep keratometry readings within 40 to 48 D.
  • 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, 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.
  • Active allergies that may inhibit contact lens wear.
  • Upper eyelid margin at or above the superior limbus.
  • History of ocular or lid surgery.
  • Immediate family members or significant others of doctors or staff at the clinical site.

Treatment and study plan

APIOC Sphere and APIOC Astigmatism

Device

Single Vision Contact Lenses

Primary outcomes

  1. Visual Acuity

    Time frame: Day 7

    High and Low Contrast LogMAR, Distance

  2. Subjective Vision Quality

    Time frame: Day 7

    Visual analogue scale

  3. Comfort

    Time frame: Day 7

    Visual analogue scale

Secondary outcomes

  1. Subjective comfort

    Time frame: Day 7

    Compared to habitual lenses

  2. Subjective vision

    Time frame: Day 7

    Compared to habitual lenses

Sponsors and collaborators

Lead sponsor

Lentechs, LLC

Industry

Registry information

Official study title

7 Day Trial of APIOC Sphere and APIOC Astigmatism

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 19, 2021
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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