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Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops

Primary Purpose

Dry Eye Syndromes, Keratoconjunctivitis Sicca, Lacrimal Apparatus Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Systane Complete
Systane Ultra
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 two eye drop exposure visits lasting approximately 6 hours each. Part 2 of the study will include using an eye drop of Systane® Complete 4x/day for 1 month and returning for one visit lasting approximately 1 hour.
  • Either gender
  • Any racial or ethnic origin
  • SVCM tear lipid thickness ≤ 75 nm
  • Contact lens wearers must refrain from lens wear for two days before the screening visit, including the day of the baseline visit, and during the entire study.

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 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.

Sites / Locations

  • The Ohio State University College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Systane® Complete

Systane® Ultra

Arm Description

All subjects are randomly assigned to arm one or arm two. Subjects are assigned to be treated with one drop of Systane® Complete, and the tear lipid layer thickness is to be measured at 15 minutes, 1, 2, 4, and 6 hours after instillation of the eye drop. Following a minimum of a 2-day washout, the same subjects will proceed to the second arm.

All subjects are randomly assigned to arm one or arm two. Subjects are assigned to be treated with one drop of Systane® Ultra, and the tear lipid layer thickness is to be measured at 15 minutes, 1, 2, 4, and 6 hours after instillation of the eye drop. Following a minimum of a 2-day washout, the same subjects will proceed to the second arm.

Outcomes

Primary Outcome Measures

Tear Lipid Layer Thickness
Interference microscopy

Secondary Outcome Measures

Tear Break-Up Time
Oculus Keratograph (K5M)

Full Information

First Posted
October 11, 2018
Last Updated
May 22, 2019
Sponsor
Ohio State University
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT03706443
Brief Title
Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops
Official Title
Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Alcon Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Cross-over comparison of lipid layer thickness and dry eye symptoms with two artificial tear formulations.
Detailed Description
This study will objectively evaluate two US lubricant eye drop formulations produced by Alcon, INC. Systane® Ultra, a non-emollient eye drop, will be compared to Systane® Complete, an emollient eye drop, 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, 4 and 6 hours after each eye drop has been instilled. Non-invasive measurements of tear break-up time will be also conducted at each visit. Subjects will then be dispensed the emollient eye drop (Systane® Complete) for use four times daily for one month and return to the study site for final measurements of dry eye symptoms, lipid layer thickness, and tear break-up time. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement, and the Oculus Keratograph (K5M) is used for non-invasive measurements of tear break-up time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Keratoconjunctivitis Sicca, Lacrimal Apparatus Diseases, Keratoconjunctivitis, Eye Diseases, Keratitis, Corneal Disease, Ophthalmic Solution

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single masked; randomized
Masking
Participant
Masking Description
Investigator instills known eye drop; masked to participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systane® Complete
Arm Type
Active Comparator
Arm Description
All subjects are randomly assigned to arm one or arm two. Subjects are assigned to be treated with one drop of Systane® Complete, and the tear lipid layer thickness is to be measured at 15 minutes, 1, 2, 4, and 6 hours after instillation of the eye drop. Following a minimum of a 2-day washout, the same subjects will proceed to the second arm.
Arm Title
Systane® Ultra
Arm Type
Active Comparator
Arm Description
All subjects are randomly assigned to arm one or arm two. Subjects are assigned to be treated with one drop of Systane® Ultra, and the tear lipid layer thickness is to be measured at 15 minutes, 1, 2, 4, and 6 hours after instillation of the eye drop. Following a minimum of a 2-day washout, the same subjects will proceed to the second arm.
Intervention Type
Other
Intervention Name(s)
Systane Complete
Intervention Description
Lubricant eye drop which is based on propylene glycol 0.6%. Used for temporary relief of burning and irritation due to dryness of the eye.
Intervention Type
Other
Intervention Name(s)
Systane Ultra
Intervention Description
Lubricant eye drop which is based on polyethylene glycol 400 0.4% and propylene glycol 0.3%. Used for temporary relief of burning and irritation due to dryness of the eye.
Primary Outcome Measure Information:
Title
Tear Lipid Layer Thickness
Description
Interference microscopy
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Tear Break-Up Time
Description
Oculus Keratograph (K5M)
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 two eye drop exposure visits lasting approximately 6 hours each. Part 2 of the study will include using an eye drop of Systane® Complete 4x/day for 1 month and returning for one visit lasting approximately 1 hour. Either gender Any racial or ethnic origin SVCM tear lipid thickness ≤ 75 nm Contact lens wearers must refrain from lens wear for two days before the screening visit, including the day of the baseline visit, and during the entire study. 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 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.
Facility Information:
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops

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