APIOC Sphere and APIOC Astigmatism

NCT04806802 | Completed FDA Device

• 1 other identifier: LEN102
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Myopia; Hyperopia; Astigmatism

Outcome Measures

Primary Outcomes (3)

• Visual Acuity

  High and Low Contrast LogMAR, Distance

  Day 7

• Subjective Vision Quality

  Visual analogue scale

  Day 7

• Comfort

  Visual analogue scale

  Day 7

Secondary Outcomes (2)

• Subjective comfort

  Day 7

• Subjective vision

  Day 7

Study Arms (1)

APIOC Sphere or Astigmatism

EXPERIMENTAL

Single Vision Spherical or Toric Contact Lens

Device: APIOC Sphere and APIOC Astigmatism

Interventions

APIOC Sphere and APIOC Astigmatism DEVICE

Single Vision Contact Lenses

APIOC Sphere or Astigmatism

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Lentechs, LLC: lead

Study Sites (6)

Complete Family Vision Care

San Diego, California, 92123, United States

Location

Eola Eyes

Orlando, Florida, 32803, United States

Location

Gaddie Eye Centers

Lexington, Kentucky, 40517, United States

Location

Miamisburg Vision Care

Miamisburg, Ohio, 45342, United States

Location

Vision Professionals

New Albany, Ohio, 43054, United States

Location

Eyecare Professionals of Powell

Powell, Ohio, 43065, United States

Location

MeSH Terms

Conditions

Myopia; Hyperopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: March 18, 2021
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)