NCT04883099

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

May 4, 2021

Last Update Submit

January 17, 2022

Conditions

PresbyopiaMyopiaHyperopiaAstigmatism

Outcome Measures

Primary Outcomes (5)

  • Visual Acuity Distance

    High and Low Contrast LogMAR

    Day 7

  • Subjective Vision Quality

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

    Day 7

  • Comfort

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

    Day 7

  • Visual Acuity Near

    High and Low Contrast

    Day 7

  • Visual Acuity Intermediate

    High and Low Contrast

    Day 7

Secondary Outcomes (2)

  • Subjective Comfort

    Day 7

  • Subjective vision Comparison

    Day 7

Study Arms (1)

APIOC for Presbyopia and Presbyopia with Astigmatism

EXPERIMENTAL

Presbyopic Spherical or Toric Contact Lens

Device: APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism

Interventions

APIOC for Presbyopia and APIOC for Presbyopia for AstigmatismDEVICE

Contact Lenses for Presbyopia

APIOC for Presbyopia and Presbyopia with Astigmatism

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

PresbyopiaMyopiaHyperopiaAstigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Thomas Quinn, OD, MS

    Athens Eye Care

    PRINCIPAL INVESTIGATOR

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

May 4, 2021

First Posted

May 12, 2021

Study Start

May 6, 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

No sharing of data is planned.

Locations

US(6)