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Tear Lipid Layer Thickness Assessments With Perfluorohexyloctane Eye Drops

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NovaTears
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dry Eye

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Age - at least 30 years

    • Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
    • Ability to give informed consent
    • Willing to spend time for the study; approximately one hour for a screening visit and 45 minutes for a data collection visit.
    • Either gender
    • Any racial or ethnic origin
    • tear lipid thickness ≤ 75 nm

Exclusion Criteria:

  • Active ocular inflammation
  • Use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and Restasis or Xiidra) used within 14 days of the screening visit or started prior to the measurement visit(s).
  • Currently having punctal plugs inserted in lacrimal puncta
  • Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to moderate or greater blepharitis and ocular allergy. Clinically significant (active treatment) of blepharitis, Sjogren's disease or other systemic disease that could influence MGD, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics, SSRIs, that could influence tear secretion, or sensitivity to any of the ingredient in the eye drop being tested,
  • Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract removal surgery more than one year ago may be considered as potential subjects.
  • Female subjects may not be pregnant or lactating. (Subject will be asked to self-report these conditions.)
  • Infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, HIV). (Subjects will be asked to self-report these conditions.)
  • Inability to complete the screening and examination
  • Inability to provide analyzable data. For example, subjects who cannot keep their eye open during the entire measurement interval (due to early blinking) or provide a readable eye image (due to eyelid laxity) or cannot sit still for 1 minute.

Sites / Locations

  • The Ohio State University College of Optometry

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Perfluorohexyloctane eye drop

Arm Description

Participants will have their tear lipid layer assessed. They will then have the eye drop instilled and will have an additional assessment of the tear lipid layer within 5 minutes of instillation of the the drop, and again 15 minutes after instillation.

Outcomes

Primary Outcome Measures

Tear lipid layer thickness

Secondary Outcome Measures

Full Information

First Posted
March 11, 2022
Last Updated
February 3, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05288582
Brief Title
Tear Lipid Layer Thickness Assessments With Perfluorohexyloctane Eye Drops
Official Title
Tear Lipid Layer Thickness Assessments With Perfluorohexyloctane Eye Drops
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to explore the tear lipid layer quantitatively and qualitatively before and after use of a perflurohexyloctane eye drop (NovaTears)
Detailed Description
The tear lipid layer will be studied before and after the use of an over-the-counter eye drop (NovaTears, Novaliq GmbH, Heidelberg, Germany) using a Stroboscopic Video Color Microscope, which is non-invasive.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will be given the eye drop and will have their tear lipid examined before and after use of the drop.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Perfluorohexyloctane eye drop
Arm Type
Other
Arm Description
Participants will have their tear lipid layer assessed. They will then have the eye drop instilled and will have an additional assessment of the tear lipid layer within 5 minutes of instillation of the the drop, and again 15 minutes after instillation.
Intervention Type
Device
Intervention Name(s)
NovaTears
Intervention Description
Over-the-counter eye drop
Primary Outcome Measure Information:
Title
Tear lipid layer thickness
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Age - at least 30 years Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI) Ability to give informed consent Willing to spend time for the study; approximately one hour for a screening visit and 45 minutes for a data collection visit. Either gender Any racial or ethnic origin tear lipid thickness ≤ 75 nm Exclusion Criteria: Active ocular inflammation Use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and Restasis or Xiidra) used within 14 days of the screening visit or started prior to the measurement visit(s). Currently having punctal plugs inserted in lacrimal puncta Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to moderate or greater blepharitis and ocular allergy. Clinically significant (active treatment) of blepharitis, Sjogren's disease or other systemic disease that could influence MGD, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics, SSRIs, that could influence tear secretion, or sensitivity to any of the ingredient in the eye drop being tested, Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract removal surgery more than one year ago may be considered as potential subjects. Female subjects may not be pregnant or lactating. (Subject will be asked to self-report these conditions.) Infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, HIV). (Subjects will be asked to self-report these conditions.) Inability to complete the screening and examination Inability to provide analyzable data. For example, subjects who cannot keep their eye open during the entire measurement interval (due to early blinking) or provide a readable eye image (due to eyelid laxity) or cannot sit still for 1 minute.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Fogt, OD MS
Organizational Affiliation
OSU College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tear Lipid Layer Thickness Assessments With Perfluorohexyloctane Eye Drops

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