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Tear Lipid Layer Thickness With Emollient Eye Drops

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03380624
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Jennifer Fogt, Ohio State University

Brief Summary:
Crossover comparison of lipid layer thickness with two artificial tear formulations

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Refresh Optive Drug: Refresh Optimum OMEGA 3 Phase 4

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, 2 and 4 hours after each eye drop has been instilled. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double masked, randomized
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Investigator instills eye drop masked to participant
Primary Purpose: Treatment
Official Title: Tear Lipid Layer Thickness With Emollient Eye Drops
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Refresh Optive
The subjects are randomly assigned to Arm one or Arm two such as in the first arm, subjects are assigned to be treated with one drop of Refresh Optive at 15 minutes, 1, 2 and four hours After which there is a washout period before proceeding to the second arm
Drug: Refresh Optive
Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose

Experimental: Refresh Optima OMEGA 3
The subjects are randomly assigned to Arm one or Arm two such as in the first arm, subjects are assigned to be treated with one drop of Refresh Optima OMEGA 3 at 15 minutes, 1, 2 and four hours After which there is a washout period before proceeding to the second arm
Drug: Refresh Optimum OMEGA 3
Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose




Primary Outcome Measures :
  1. Lipid Layer Thickness [ Time Frame: 1 minute ]
    Interference microscopy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 5 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380624


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Allergan
Investigators
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Principal Investigator: Joseph Barr, OD Ohio State University

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Responsible Party: Jennifer Fogt, Associate Clinical Professor - Practice, Ohio State University
ClinicalTrials.gov Identifier: NCT03380624    
Other Study ID Numbers: 2016H0354
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Emollients
Ophthalmic Solutions
Pharmaceutical Solutions
Dermatologic Agents