Dry Eye Syndromes
Conditions
Brief summary
Crossover comparison of lipid layer thickness with two artificial tear formulations
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 hour after each eye drop has been instilled. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement.
Interventions
DRUGRefresh Optive
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
Sponsors
Allergan
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Double masked, randomized
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear Lipid Layer Thickness | 15 minutes | Change in tear lipid layer thickness |
Countries
United States
Participant flow
Pre-assignment details
2 participants were found to be ineligible after completing the baseline visit.
Participants by arm
| Arm | Count |
|---|---|
| Refresh Optive and Refresh Optive MEGA The subjects are randomly assigned to Refresh Optive or Refresh Optive MEGA (Omega 3) with measurements of lipid layer thickness following at 15 minutes and 1 hour.
After which there is a washout period before proceeding to the second eye drop at visit 2.
Refresh Optive: Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose
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
\*All subjects completed both arms in this crossover study | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Refresh Optive and Refresh Optive MEGA | — |
|---|---|---|
| Age, Customized Age 30 to 65 | 19 Participants | — |
| Lipid layer thickness | 40.9 nm STANDARD_DEVIATION 10.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Change in Tear Lipid Layer Thickness
Change in tear lipid layer thickness
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refresh Optive | Change in Tear Lipid Layer Thickness | 4.8 nm | Standard Deviation 14.9 |
| Refresh Optive MEGA-3 | Change in Tear Lipid Layer Thickness | 8.8 nm | Standard Deviation 11.5 |