Tear Lipid Layer Thickness Assessments With Perfluorohexyloctane Eye Drops

NCT05288582 | Completed

• 1 other identifier: 2021H0436
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Tear lipid layer thickness

  15 minutes

Study Arms (1)

Perfluorohexyloctane eye drop

OTHER

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.

Device: NovaTears

Interventions

NovaTears DEVICE

Over-the-counter eye drop

Perfluorohexyloctane eye drop

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Jennifer Fogt, OD MS

  OSU College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: All participants will be given the eye drop and will have their tear lipid examined before and after use of the drop.

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 21, 2022
• Study Start: March 27, 2022
• Primary Completion: July 31, 2022
• Study Completion: November 30, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)