Status:
COMPLETED
Tear Lipid Layer Thickness With Emollient Eye Drops
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Allergan
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
30+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03380624
Start Date
March 1 2017
End Date
June 30 2018
Last Update
February 3 2021
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210