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Corneal Oxygen Uptake With Apioc Contact Lenses

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apioc Contact Lens
Sponsored by
Lentechs, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Rev1 Ventures

Outcomes

Primary Outcome Measures

Corneal Oxygen Uptake Rate
uptake of oxygen by human cornea in vivo

Secondary Outcome Measures

Full Information

First Posted
July 22, 2019
Last Updated
October 9, 2023
Sponsor
Lentechs, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04031118
Brief Title
Corneal Oxygen Uptake With Apioc Contact Lenses
Official Title
Corneal Oxygen Uptake With Apioc Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lentechs, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Apioc Contact Lens
Intervention Description
Measurement of corneal oxygen uptake with contact lens wear.
Primary Outcome Measure Information:
Title
Corneal Oxygen Uptake Rate
Description
uptake of oxygen by human cornea in vivo
Time Frame
up to 45 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provide informed consent. Appear willing and able to adhere to instructions set forth in the protocol. Be between the ages of 18 and 45. Be an experienced contact lens wearer. Be an eyecare clinician or clinician-in-training. Flat and steep keratometry readings within 40 to 50D. Clear, healthy corneas with no irregular astigmatism. Normal, healthy conjunctiva in both eyes. Be able to provide corneal topography measurements. Be able to provide manifest refraction measurements. Exclusion Criteria: Irregular corneal astigmatism. Use of topical or systemic antihistamines within the previous week. Use of topical ophthalmic drops within the previous two days. History of corneal surgery. Currently pregnant or lactating. Systemic disease that would interfere with contact lens wear. Previous diagnosis of dry eye syndrome.
Facility Information:
Facility Name
Rev1 Ventures
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States

12. IPD Sharing Statement

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Corneal Oxygen Uptake With Apioc Contact Lenses

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