Clinical trial NCT03706443: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Eye Diseases
Keratitis
Corneal Disease
Ophthalmic Solution
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2018-10-16
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single masked; randomized
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Tear Lipid Layer Thickness
timeFrame: 1 minute
Secondary outcomes:
measure: Tear Break-Up Time
timeFrame: 1 minute
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
References: