Tear Lipid Layer Thickness With Emollient Eye Drops

Crossover comparison of lipid layer thickness with two artificial tear formulations

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Refresh Optive; Drug: Refresh Optive MEGA-3

Detailed Description

This study will objectively evaluate two US Monograph lubricant eyedrop formulations (Allergan, plc). Refresh Optive ADVANCED will be compared to an investigational formula with additional compendial ingredients (Refresh Optive MEGA 3) in subjects with dry eye symptoms and lipid layer thickness < 75 nm at baseline in a randomized, cross-over (masked subject) design. We seek to objectively evaluate the increase in lipid layer thickness from baseline at 15 minutes and 1 hour after each eye drop has been instilled. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 additional 4 hours for the study assessments. Study assessment will be conducted over 2 visit days, approximately 1 1/2 hours per day.
  • Either gender
  • Any racial or ethnic origin
  • Stroboscopic Video Color Microscope tear lipid thickness ≤ 75 nm

Exclusion Criteria:

• Use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and Restasis) 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 Meibomian Gland Dysfunction, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics or drugs 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, but less than 10 years 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Refresh Optive, then Refresh Optive MEGA-3; Participants first utilized one drop of Refresh Optive in each eye before taking lipid layer thickness measurements occurring at 15 minutes and 1 hour after instillation. After a washout period, they returned to repeat the testing using one drop of Refresh Optive MEGA-3 before taking lipid layer thickness measurements. .	Drug: Refresh Optive; Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose; Drug: Refresh Optive MEGA-3; Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose
Experimental: Refresh Optive MEGA-3, then Refresh Optive; Participants first utilized one drop of Refresh Optive MEGA-3 in each eye before taking lipid layer thickness measurements occurring at 15 minutes and 1 hour after instillation. After a washout period, they returned to repeat the testing using one drop of Refresh Optive before taking lipid layer thickness measurements.	Drug: Refresh Optive; Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose; Drug: Refresh Optive MEGA-3; Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Tear Lipid Layer Thickness	Change in tear lipid layer thickness	15 minutes

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Allergan
• Investigators: Principal Investigator: Jennifer Fogt, OD MS, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 14, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 2016H0354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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