Tear Lipid Layer Thickness With Emollient Eye Drops

NCT ID: NCT03380624

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-06-30

Brief Summary

Crossover comparison of lipid layer thickness with two artificial tear formulations

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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

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Group Type: EXPERIMENTAL

Refresh Optive

Intervention Type: DRUG

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

Refresh Optive MEGA-3

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Refresh Optive

Intervention Type: DRUG

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

Refresh Optive MEGA-3

Intervention Type: DRUG

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

Interventions

Refresh Optive

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

Intervention Type: 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

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Fogt

Associate Clinical Professor - Practice

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Fogt, OD MS

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2016H0354

Identifier Type: -

Identifier Source: org_study_id