Back to resultsApioc Presbyopic Contact Lens
Primary Purpose
Presbyopia, Refractive Errors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apioc-P and Apioc-PT Contact Lens Design
Sponsored by
About this trial
This is an interventional device feasibility trial for Presbyopia focused on measuring contact lens, soft contact lens
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.
- ≤ 4.00 D of refractive astigmatism.
- Refractive error range +20.00 DS to -20.00 DS
- Keratometry readings within 40 to 50D.
- 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 12 months) 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. Use of artificial tears less than 3 times 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 4D 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.
Sites / Locations
- Quinn Foster & Associates
- EyeCare Professionals of Powell
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Apioc Lens
Arm Description
All subjects will wear either the Apioc-P or Apioc-PT contact lens design
Outcomes
Primary Outcome Measures
Visual Acuity
LogMAR visual acuity
Secondary Outcome Measures
Comfort
Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04437732
Brief Title
Apioc Presbyopic Contact Lens
Official Title
30 Day Trial Fitting of a New Bifocal Contact Lens
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
June 9, 2021 (Actual)
Study Completion Date
June 9, 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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way you wear your current contact lenses for approximately one month (no more than 35 days).
Detailed Description
Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved by the U.S. Food and Drug Administration (FDA), although the contact lens material, called Definitive 74, is already approved and marketed for contact lenses that are similar to Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact lens the way they wear their current contact lenses for approximately one month (no more than 35 days).
Participation in this study will include a minimum of four study visits. The first will last up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45 minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be fitting properly at the second visit, then another lens will be ordered for participants and they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects will participate in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbyopia, Refractive Errors
Keywords
contact lens, soft contact lens
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apioc Lens
Arm Type
Other
Arm Description
All subjects will wear either the Apioc-P or Apioc-PT contact lens design
Intervention Type
Device
Intervention Name(s)
Apioc-P and Apioc-PT Contact Lens Design
Intervention Description
Novel soft contact lens design
Primary Outcome Measure Information:
Title
Visual Acuity
Description
LogMAR visual acuity
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Comfort
Description
Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).
Time Frame
30 days
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.
≤ 4.00 D of refractive astigmatism.
Refractive error range +20.00 DS to -20.00 DS
Keratometry readings within 40 to 50D.
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 12 months) 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. Use of artificial tears less than 3 times 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 4D 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas G Quinn, OD, MS, FAAO
Organizational Affiliation
Drs. Quinn, Foster & Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason R Miller, OD, MBA
Organizational Affiliation
Eyecare Professionals of Powell
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quinn Foster & Associates
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
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
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Apioc Presbyopic Contact Lens
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