Clinical trial NCT04806802: APIOC Sphere and APIOC Astigmatism
Official title: 7 Day Trial of APIOC Sphere and APIOC Astigmatism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Astigmatism
Lead sponsor: Lentechs, LLC
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual Acuity
timeFrame: Day 7
measure: Subjective Vision Quality
timeFrame: Day 7
measure: Comfort
timeFrame: Day 7
Secondary outcomes:
measure: Subjective comfort
timeFrame: Day 7
measure: Subjective vision
timeFrame: Day 7
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Complete Family Vision Care
state: California
city: Orlando
country: United States
facility: Eola Eyes
state: Florida
city: Lexington
country: United States
facility: Gaddie Eye Centers
state: Kentucky
city: Miamisburg
country: United States
facility: Miamisburg Vision Care
state: Ohio
city: New Albany
country: United States
facility: Vision Professionals
state: Ohio
city: Powell
country: United States
facility: Eyecare Professionals of Powell
state: Ohio
Study officials:
References: