Corneal Oxygen Uptake With Apioc Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)
• Intervention / Treatment: Device: Apioc Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Rev1 Ventures

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Oxygen Uptake Rate	uptake of oxygen by human cornea in vivo	up to 45 seconds

Collaborators and Investigators

• Sponsor: Lentechs, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases
• Other Study ID Numbers: Len-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No