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OpenTrials
Completed

NCT Number: NCT04883099

APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

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

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Key information

Age range

40 year–70 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 40 years of age and no more than 70 years of age.
  • ≤ 4.00 D of corneal astigmatism.
  • ≤ 2.50 D of refractive astigmatism.
  • Refractive error range +4.00 DS to -6.00 DS
  • Require a reading addition (bifocal) of at least 0.75 D
  • 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 and presbyopia are permitted.
  • Be a current or former (within the last 3 years) contact lens wearer.
  • Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion criteria

  • Irregular corneal astigmatism.
  • 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. Occasional artificial tear use 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 for Presbyopia and APIOC for Presbyopia for Astigmatism

Device

Contact Lenses for Presbyopia

Primary outcomes

  1. Visual Acuity Distance

    Time frame: Day 7

    High and Low Contrast LogMAR

  2. Subjective Vision Quality

    Time frame: Day 7

    Visual analogue scale (0-100 points) 100 is best possible quality of vision

  3. Comfort

    Time frame: Day 7

    Visual analogue scale(0-100 points) 100 is best possible comfort

  4. Visual Acuity Near

    Time frame: Day 7

    High and Low Contrast

  5. Visual Acuity Intermediate

    Time frame: Day 7

    High and Low Contrast

Secondary outcomes

  1. Subjective Comfort

    Time frame: Day 7

    Compared to habitual lenses, rated as better/same/worse

  2. Subjective vision Comparison

    Time frame: Day 7

    Compared to habitual lenses, rated as better/same/worse

Sponsors and collaborators

Lead sponsor

Lentechs, LLC

Industry

Registry information

Official study title

7 Day Trial of APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 12, 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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