Tear Lipid Layer Thickness With Emollient Eye Drops

NCT03380624 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2016H0354
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Crossover comparison of lipid layer thickness with two artificial tear formulations

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Change in Tear Lipid Layer Thickness

  Change in tear lipid layer thickness

  15 minutes

Study Arms (2)

Refresh Optive, then Refresh Optive MEGA-3

EXPERIMENTAL

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; Drug: Refresh Optive MEGA-3

Refresh Optive MEGA-3, then Refresh Optive

EXPERIMENTAL

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; Drug: Refresh Optive MEGA-3

Interventions

Refresh Optive DRUG

Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose

Refresh Optive MEGA-3, then Refresh Optive; Refresh Optive, then Refresh Optive MEGA-3

Refresh Optive MEGA-3 DRUG

Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose

Refresh Optive MEGA-3, then Refresh Optive; Refresh Optive, then Refresh Optive MEGA-3

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Allergan: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jennifer Fogt
• Organization: The Ohio State University College of Optometry

fogt.78@osu.edu

614-292-2020

Study Officials

• Jennifer Fogt, OD MS

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Investigator instills eye drop masked to participant. While this is a single arm study in that all participants receive both eye drops, the order in which they are used is randomized and masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor - Practice

Model Details: Double masked, randomized

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: December 21, 2017
• Study Start: March 1, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)