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APIOC Sphere and APIOC Astigmatism

Primary Purpose

Myopia, Hyperopia, Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APIOC Sphere and APIOC Astigmatism
Sponsored by
Lentechs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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 18 years of age and no more than 35 years of age.
  4. ≤ 4.00 D (diopters) of corneal astigmatism.
  5. ≤ 2.50 D of refractive astigmatism.
  6. Refractive error range +4.00 DS to -6.00 DS (diopters sphere)
  7. Flat and steep keratometry readings within 40 to 48 D.
  8. Clear, healthy corneas with no irregular astigmatism.
  9. Normal, healthy conjunctiva in both eyes.
  10. Free of active ocular disease. Refractive error is permitted.
  11. Be a current or former (within the last 12 months) contact lens wearer.
  12. Best-corrected near and distance visual acuity better than or equal to 20/25.

Exclusion Criteria:

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

Sites / Locations

  • Complete Family Vision Care
  • Eola Eyes
  • Gaddie Eye Centers
  • Miamisburg Vision Care
  • Vision Professionals
  • Eyecare Professionals of Powell

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

APIOC Sphere or Astigmatism

Arm Description

Single Vision Spherical or Toric Contact Lens

Outcomes

Primary Outcome Measures

Visual Acuity
High and Low Contrast LogMAR, Distance
Subjective Vision Quality
Visual analogue scale
Comfort
Visual analogue scale

Secondary Outcome Measures

Subjective comfort
Compared to habitual lenses
Subjective vision
Compared to habitual lenses

Full Information

First Posted
March 17, 2021
Last Updated
January 17, 2022
Sponsor
Lentechs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04806802
Brief Title
APIOC Sphere and APIOC Astigmatism
Official Title
7 Day Trial of APIOC Sphere and APIOC Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lentechs, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Hyperopia, Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APIOC Sphere or Astigmatism
Arm Type
Experimental
Arm Description
Single Vision Spherical or Toric Contact Lens
Intervention Type
Device
Intervention Name(s)
APIOC Sphere and APIOC Astigmatism
Intervention Description
Single Vision Contact Lenses
Primary Outcome Measure Information:
Title
Visual Acuity
Description
High and Low Contrast LogMAR, Distance
Time Frame
Day 7
Title
Subjective Vision Quality
Description
Visual analogue scale
Time Frame
Day 7
Title
Comfort
Description
Visual analogue scale
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Subjective comfort
Description
Compared to habitual lenses
Time Frame
Day 7
Title
Subjective vision
Description
Compared to habitual lenses
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Complete Family Vision Care
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Eola Eyes
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Gaddie Eye Centers
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Facility Name
Miamisburg Vision Care
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
Facility Name
Vision Professionals
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
Eyecare Professionals of Powell
City
Powell
State/Province
Ohio
ZIP/Postal Code
43065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing of data is planned.

Learn more about this trial

APIOC Sphere and APIOC Astigmatism

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