Clinical trial NCT03970512: Apioc Toric/Spherical Single Vision Contact Lens
Official title: 30 Day Fitting of a New Toric Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Keywords: contact lens
soft contact lens
Lead sponsor: Lentechs, LLC
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.


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 of corneal astigmatism.
5. ≤ 4.00 D of refractive astigmatism.
6. Refractive error range +20.00 DS to -20.00 DS
7. Flat and steep keratometry readings within 40 to 50D.
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.
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.

Primary outcomes:
measure: Visual Acuity
timeFrame: 30 days
Secondary outcomes:
measure: Comfort
timeFrame: 30 days
measure: Rotational Stability of Apioc-A
timeFrame: 30 days
Other outcomes:
Locations:
city: Athens
country: United States
facility: Quinn Foster & Associates
state: Ohio
city: Powell
country: United States
facility: EyeCare Professionals of Powell
state: Ohio
Study officials:
affiliation: Drs. Quinn, Foster & Associates
name: Thomas G Quinn, OD, MS, FAAO
role: PRINCIPAL_INVESTIGATOR
affiliation: Eyecare Professionals of Powell
name: Jason R Miller, OD, MBA
role: PRINCIPAL_INVESTIGATOR
References: