APIOC Sphere and APIOC Astigmatism

Completed · Not applicable

Conditions studied: Myopia, Hyperopia, Astigmatism

In brief

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.

Key facts

Study ID

NCT04806802

Run by

Lentechs, LLC

People needed

50

Starts

2021-03-18

Expected to finish

2021-10-31

Last updated by the study team

2022-01-19

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Complete Family Vision Care — San Diego, California, United States
• Eola Eyes — Orlando, Florida, United States
• Gaddie Eye Centers — Lexington, Kentucky, United States
• Miamisburg Vision Care — Miamisburg, Ohio, United States
• Vision Professionals — New Albany, Ohio, United States
• Eyecare Professionals of Powell — Powell, Ohio, United States

Full record on ClinicalTrials.gov

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