APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

Study Overview
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Brief Summary
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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.

Official Title
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7 Day Trial of APIOC for Presbyopia and APIOC for Presbyopia With Astigmatism

Conditions
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Myopia, Presbyopia, Hyperopia, Astigmatism

Intervention / Treatment
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* Device: APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APIOC for Presbyopia and Presbyopia with Astigmatism<br>Presbyopic Spherical or Toric Contact Lens | Device: APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism<br>* Contact Lenses for Presbyopia<br>|

What is the study measuring?
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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 |