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

NCT03706443 | Completed

• 1 other identifier: 2018H0433
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Cross-over comparison of lipid layer thickness and dry eye symptoms with two artificial tear formulations.

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Eye Diseases; Keratitis; Corneal Disease; Ophthalmic Solution

Outcome Measures

Primary Outcomes (1)

• Tear Lipid Layer Thickness

  Interference microscopy

  1 minute

Secondary Outcomes (1)

• Tear Break-Up Time

  1 minute

Study Arms (2)

Systane® Complete

ACTIVE COMPARATOR

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.

Other: Systane Complete

Systane® Ultra

ACTIVE COMPARATOR

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.

Other: Systane Ultra

Interventions

Systane Complete OTHER

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.

Systane® Complete

Systane Ultra OTHER

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.

Systane® Ultra

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 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.

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 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.

Sponsors & Collaborators

• Ohio State University: lead
• Alcon Research: collaborator

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Eye Diseases; Keratitis; Corneal Diseases

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Investigator instills known eye drop; masked to participant
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single masked; randomized

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 16, 2018
• Study Start: December 5, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)