Tear Lipid Layer Thickness With Emollient Eye Drops

The Ohio State University

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Refresh Optive MEGA-3; Drug: Refresh Optive

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03380624

2016H0354

Details and patient eligibility

About

Crossover comparison of lipid layer thickness with two artificial tear formulations

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

21 participants in 2 patient groups

Refresh Optive, then Refresh Optive MEGA-3

Experimental group

Description:

Participants first utilized one drop of Refresh Optive in each eye before taking lipid layer thickness measurements occurring at 15 minutes and 1 hour after instillation. After a washout period, they returned to repeat the testing using one drop of Refresh Optive MEGA-3 before taking lipid layer thickness measurements. .

Treatment:

Drug: Refresh Optive

Drug: Refresh Optive MEGA-3

Refresh Optive MEGA-3, then Refresh Optive

Experimental group

Description:

Participants first utilized one drop of Refresh Optive MEGA-3 in each eye before taking lipid layer thickness measurements occurring at 15 minutes and 1 hour after instillation. After a washout period, they returned to repeat the testing using one drop of Refresh Optive before taking lipid layer thickness measurements.

Treatment:

Drug: Refresh Optive

Drug: Refresh Optive MEGA-3