Tear Lipid Layer Thickness With Emollient Eye Drops
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: Refresh Optive; Refresh Optive MEGA-3
Intervention description: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose; Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
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. While this is a single arm study in that all participants receive both eye drops, the order in which they are used is randomized and masked.
Enrollment: 21.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Crossover comparison of lipid layer thickness with two artificial tear formulations
    

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.