Corneal Oxygen Uptake With Apioc Contact Lenses | NCT04031118

Studies
Corneal Oxygen Uptake With Apioc Contact Lenses

NCT04031118

Sponsor

Lentechs, LLC

Status

Completed

Last Update Posted

Oct 10, 2023Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

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

Interventions

Apioc Contact Lens

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2019Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Nov 1, 2022Actual

First Submitted Date

Jul 22, 2019

First Submission Date that Met QC Criteria

Jul 22, 2019

First Posted Date

Jul 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2023

Last Update Posted Date

Oct 10, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Apioc Contact Lens	Device	Measurement of corneal oxygen uptake with contact lens wear.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rev1 Ventures		Columbus	Ohio	43212	United States

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 22, 2018	Jul 22, 2019	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided