APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

7 Day Trial of 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.

Study Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Complete Family Vision Care
  • Florida
    • Orlando, Florida, United States, 32803
      • Eola Eyes
  • Kentucky
    • Lexington, Kentucky, United States, 40517
      • Gaddie Eye Centers
  • Ohio
    • Miamisburg, Ohio, United States, 45342
      • Miamisburg Vision Care
    • New Albany, Ohio, United States, 43054
      • Vision Professionals
    • Powell, Ohio, United States, 43065
      • EyeCare Professionals of Powell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject must provide written informed consent.
2. The subject must appear willing and able to adhere to the instructions set forth in this protocol.
3. At least 40 years of age and no more than 70 years of age.
4. ≤ 4.00 D of corneal astigmatism.
5. ≤ 2.50 D of refractive astigmatism.
6. Refractive error range +4.00 DS to -6.00 DS
7. Require a reading addition (bifocal) of at least 0.75 D
8. Flat and steep keratometry readings within 40 to 48 D.
9. Clear, healthy corneas with no irregular astigmatism.
10. Normal, healthy conjunctiva in both eyes.
11. Free of active ocular disease. Refractive error and presbyopia are permitted.
12. Be a current or former (within the last 3 years) contact lens wearer.
13. Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria:

1. Irregular corneal astigmatism.
2. Corneal scarring unless off line-of-site and well healed.
3. Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
4. 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.
5. Systemic disease that would interfere with contact lens wear.
6. Currently pregnant or lactating (by self-report).
7. 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.
8. Active allergies that may inhibit contact lens wear.
9. Upper eyelid margin at or above the superior limbus.
10. History of ocular or lid surgery.
11. Immediate family members or significant others of doctors or staff at the clinical site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APIOC for Presbyopia and Presbyopia with Astigmatism; Presbyopic Spherical or Toric Contact Lens	Device: APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism; Contact Lenses for Presbyopia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Comfort	Compared to habitual lenses, rated as better/same/worse	Day 7
Subjective vision Comparison	Compared to habitual lenses, rated as better/same/worse	Day 7

Collaborators and Investigators

• Sponsor: Lentechs, LLC
• Investigators: Principal Investigator: Thomas Quinn, OD, MS, Athens Eye Care

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Astigmatism; Hyperopia
• Other Study ID Numbers: LEN101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing of data is planned.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes