Corneal Oxygen Uptake With Apioc Contact Lenses

Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis) Clinical Trial

Official title:

Corneal Oxygen Uptake With Apioc Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031118
• Other study ID #: Len-003
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2023
• Source: Lentechs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Provide informed consent.

2. Appear willing and able to adhere to instructions set forth in the protocol.

3. Be between the ages of 18 and 45.

4. Be an experienced contact lens wearer.

5. Be an eyecare clinician or clinician-in-training.

6. Flat and steep keratometry readings within 40 to 50D.

7. Clear, healthy corneas with no irregular astigmatism.

8. Normal, healthy conjunctiva in both eyes.

9. Be able to provide corneal topography measurements.

10. Be able to provide manifest refraction measurements.

Exclusion Criteria:

1. Irregular corneal astigmatism.

2. Use of topical or systemic antihistamines within the previous week.

3. Use of topical ophthalmic drops within the previous two days.

4. History of corneal surgery.

5. Currently pregnant or lactating.

6. Systemic disease that would interfere with contact lens wear.

7. Previous diagnosis of dry eye syndrome.

Related Conditions & MeSH terms

• Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)
• Corneal Diseases

Intervention

Device:
• Apioc Contact Lens
Measurement of corneal oxygen uptake with contact lens wear.

Locations

Country	Name	City	State
United States	Rev1 Ventures	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Lentechs, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Oxygen Uptake Rate	uptake of oxygen by human cornea in vivo	up to 45 seconds