APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
Primary Purpose
Presbyopia, Myopia, Hyperopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism
Sponsored by
About this trial
This is an interventional treatment trial for Presbyopia
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 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.
Exclusion Criteria:
- 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.
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 for Presbyopia and Presbyopia with Astigmatism
Arm Description
Presbyopic Spherical or Toric Contact Lens
Outcomes
Primary Outcome Measures
Visual Acuity Distance
High and Low Contrast LogMAR
Subjective Vision Quality
Visual analogue scale (0-100 points) 100 is best possible quality of vision
Comfort
Visual analogue scale(0-100 points) 100 is best possible comfort
Visual Acuity Near
High and Low Contrast
Visual Acuity Intermediate
High and Low Contrast
Secondary Outcome Measures
Subjective Comfort
Compared to habitual lenses, rated as better/same/worse
Subjective vision Comparison
Compared to habitual lenses, rated as better/same/worse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04883099
Brief Title
APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
Official Title
7 Day Trial of APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 6, 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
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™ for Presbyopia or the APIOC™ for Presbyopia Astigmatism contact lenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, 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 for Presbyopia and Presbyopia with Astigmatism
Arm Type
Experimental
Arm Description
Presbyopic Spherical or Toric Contact Lens
Intervention Type
Device
Intervention Name(s)
APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism
Intervention Description
Contact Lenses for Presbyopia
Primary Outcome Measure Information:
Title
Visual Acuity Distance
Description
High and Low Contrast LogMAR
Time Frame
Day 7
Title
Subjective Vision Quality
Description
Visual analogue scale (0-100 points) 100 is best possible quality of vision
Time Frame
Day 7
Title
Comfort
Description
Visual analogue scale(0-100 points) 100 is best possible comfort
Time Frame
Day 7
Title
Visual Acuity Near
Description
High and Low Contrast
Time Frame
Day 7
Title
Visual Acuity Intermediate
Description
High and Low Contrast
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Subjective Comfort
Description
Compared to habitual lenses, rated as better/same/worse
Time Frame
Day 7
Title
Subjective vision Comparison
Description
Compared to habitual lenses, rated as better/same/worse
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 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 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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Quinn, OD, MS
Organizational Affiliation
Athens Eye Care
Official's Role
Principal Investigator
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 for Presbyopia and APIOC for Presbyopia With Astigmatism
We'll reach out to this number within 24 hrs