APIOC Sphere and APIOC Astigmatism

Myopia Clinical Trial

Official title:

7 Day Trial of APIOC Sphere and APIOC Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806802
• Other study ID #: LEN102
• Status: Completed
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2022
• Source: Lentechs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Myopia

Intervention

Device:
• APIOC Sphere and APIOC Astigmatism
Single Vision Contact Lenses

Locations

Country	Name	City	State
United States	Gaddie Eye Centers	Lexington	Kentucky
United States	Miamisburg Vision Care	Miamisburg	Ohio
United States	Vision Professionals	New Albany	Ohio
United States	Eola Eyes	Orlando	Florida
United States	Eyecare Professionals of Powell	Powell	Ohio
United States	Complete Family Vision Care	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Lentechs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	High and Low Contrast LogMAR, Distance	Day 7
Primary	Subjective Vision Quality	Visual analogue scale	Day 7
Primary	Comfort	Visual analogue scale	Day 7
Secondary	Subjective comfort	Compared to habitual lenses	Day 7
Secondary	Subjective vision	Compared to habitual lenses	Day 7