Corneal Oxygen Uptake With Apioc Contact Lenses

Not Applicable

Completed

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

• Registration Number: NCT04031118
• Lead Sponsor: Lentechs, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2019-07-22
• Study First Posted: 2019-07-24
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Corneal Oxygen Uptake Rate	up to 45 seconds	uptake of oxygen by human cornea in vivo

Trial Locations

Locations (1)

Rev1 Ventures; 🇺🇸 Columbus, Ohio, United States