Heads up, dry eye clinicians: TearRestore is introducing a new artificial tear to its line of dry eye relief products: Tearstore One Drop, formulated with a preservative-free (PF) solution.
And as part of this launch, Glance President Jaclyn Garlich, OD, FAAO, spoke with one clinician with extensive—and firsthand—knowledge of all things OneDrop-related.
Big news! First, though, give me the rundown on TearRestore.
We’ll go back to 2018, when TearRestore was originally founded out of the University of Minnesota with funding from the National Science Foundation.
Since then, it’s grown into an over-the-counter (OTC) eyecare product-based medical technology company developing solutions that offer symptom relief for dry eye patients.
- From warm compresses to eyelid hygiene and serums, check out its product storefront.
There’s been a few product launches in recent years, right?
Indeed. See here for our coverage on a few of them—including last year’s launch of the “first-of-its-kind” WINQ Eyelid SERUM, formulated to address digital eye strain.
Now to this latest addition.
TearRestore OneDrop is an artificial tear intended for daily, over-the-counter (OTC) use to relieve symptoms of dry, irritated eyes.
Specifically: It’s marketed as a next-generation, soft contact lens-compatible, preservative-free (PF) ophthalmic nanoemulsion engineered to restore tear film homeostasis in patients with:
- Evaporative dry eye disease (DED)
- Aqueous-deficient DED
- Mixed etiology DED
Expand on these target patients.
OneDrop is formulated to cover “all the bases in dry eye therapy,” according to Omar Awad, MD, FACS, in practice at Minnesota Eye Consultants as well as medical director of LasikPlus Minnesota, and president of the Minnesota Eye Foundation.
As an ophthalmic surgeon, Dr. Awad said the drop is ideal for patients’ pre- and postoperative treatment to optimize the ocular surface.
As for actual real-world use so far: While he has not yet used the drop on his patients, Dr. Awad shared his own personal experience of administering the drop over his monovision contact lenses.
- “I was amazed at how much relief it gave—my vision was immediately clear and didn’t blur at all.”
So tell me about this formulation.
The drop is formulated as a stable < 100 nm nanoemulsion designed to reinforce all three layers of the natural tear film—enabling each droplet to spread evenly across the eye and provide hydration without blurry vision.
- Its active ingredient is propylene glycol 0.6%, an ophthalmic lubricant (demulcent) agent that provides relief to dry eyes by:
- Forming a protective, viscoelastic layer over the ocular surface to relieve inflammation and/or irritation
- Holding up to three times its own weight in water to maintain moisture
- Increasing viscosity to improve an eye drop's lubrication
In other words: It mimics natural tears.
Talk about these tear film stability properties.
Dr. Awad offered a rundown on OneDrop’s components.
Tell me more about the drop’s other ingredients.
OneDrop’s formulation integrates active propylene glycol with:
- Sodium hyaluronate
- Provides exceptional water-retentive capacity, rheological behavior that enhances tear residence time, as well as cell adhesion and migration support to promote ocular surface recovery.
- Dimyristoyl phosphatidylcholine (DMPC)
- To reinforce the lipid layer, this integrates with natural meibomian lipids, stabilizes the lipid layer and reduces excessive evaporation, and balances surface tension during blink mechanics—all essential for evaporative dry and meibomian gland dysfunction (MGD) patients.
- Castor oil
- Supports the tear film’s lipid layer via surfactant properties that stabilize the nanoemulsion to prevent moisture loss upon application.
Why castor oil: As explored in prior coverage, castor oil has proven valid and beneficial for significantly improving tear film instability in MGD.
Speaking of application … how often should the drop be administered?
As its name implies: once (or twice, if so desired).
No shaking of the 10 mL bottle is required beforehand.
And from a regulatory standpoint, is OneDrop cleared by the FDA?
The artificial tear is listed as an OTC artificial tear and has received clearance as an OTC monograph drug under the FDA’s Ophthalmic Drug Products for OTC Human Use (dubbed M018), which applies to ophthalmic drugs reserved for topical administration.
- What this means: It has undergone the FDA’s monograph process, met the necessary requirements for non-prescription-based products—and is allowed to be commercially marketed in the U.S.
Go on …
Additionally: TearRestore reported that OneDrop’s patent formulation has also undergone extensive clinical study by Laboratorios Sophia (its manufacturer) under the NanoDrop brand name.
See here and here for some of that research, published in Contact Lens and Anterior Eye and the Journal of Ophthalmology, respectively.
- Take note: These evaluations helped establish both the clinical and formulation foundation for the technology utilized in OneDrop.
Nice! So where can this be purchased?
Head over to the TearRestore online shop for pricing and shipping information.
Or click here for a sample.