Dr. Frank Holly PhD, FAAO, invented FreshKote® after 40 years of research. With its patented synergistic blend of polymers, FreshKote is a superior dry eye lubricant and is unlike any other dry eye product on the market.
2% Polyvinyl pyrrolidone
0.9% Polyvinyl alcohol (87% hydrolyzed)
1.8% Polyvinyl alcohol (99% hydrolyzed)
Also contains Amisol™ CLEAR
The FreshKote formula has 4 distinct advantages to the ocular surface.
In dry eye, the epithelium may become damaged and/or loosened allowing water to build up in the epithelium in the form of microcystic edema (swelling). This may lead to recurrent corneal erosions and other problems.
The high oncotic pressure in FreshKote compresses the epithelium, re-establishes the integrity of the epithelium, and also assists in removing excess water from the epithelium.
65mmHg – optimal amount
Re-establish integrity of epithelium
Reduce microcystic edema
Prevent recurrent damage
The unique blending of polymers allows FreshKote to adhere to the dry areas of the eye – completely wetting the ocular surface. This ensures that FreshKote will stay on the ocular surface and provide longer relief.
Helps to restore proper osmolarity of tear film
Dry eye occurs when eyes do not produce the right quality of tears. Women are more frequently affected than men, and it is often caused by hormonal changes due to aging and menopause or medical conditions.
Eyes need a constant layer of tears (which is called tear film) to maintain and protect the ocular surface. Changes to the health of the tear producing glands can result in a change in the quality of the tears made. This results in a tear film that can no longer provide enough of the important nourishment or protection for the surface of the eye.
RESTORES LIPID LAYER
According to USA National Eye Institute/NIH on average 75% of dry eye has an evaporative component.
When the human lipid layer is compromised due to a meibomian gland dysfunction and an absent or unstable tear film, tear evaporation is increased four-fold. With evaporative dry eye the lipid layer is thinning, exposing the aqueous layer, allowing tear evaporation and destabilizing the tear film. Over time as evaporative dry eye is left untreated a dry spot can form.
FreshKote utilizes Amisol® CLEAR which helps restore and replenish the lipid layer to stabilize the tear film and delay evaporation.
FreshKote is also preserved with a patented, non-irritating and effective preservative, Polixetonium:
Polixetonium exhibits potent antimicrobial and antifungal activity
Polixetonium eshibits extremely low ocular irritancy compared to Benzalkonium Chloride (BAK)
Polixetonium facilitates the wetting of surfaces, even contact lenses
Full Prescribing Information
LUBRICANT EYE DROPS
STERILE OPHTHALMIC SOLUTION
Each mL of FreshKote® Ophthalmic Solution contains: Polyvinyl pyrrolidone 2.0%, Polyvinyl alcohol (87% hydrolyzed) 0.9%, Polyvinyl alcohol (99% hydrolyzed) 1.8%. Also contains Amisol® CLEAR. Other ingredients: Sodium chloride, Potassium chloride, Boric acid, Purified water and as preservatives Disodium edetate dihydrate, Polixetonium.
FreshKote® sterile ophthalmic solution is a lubricant indicated for the treatment of moderate to severe dry eye.
FreshKote® is contraindicated in patients with known severe hypersensitivity to any of the ingredients in the formulation.
To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
Do not use if solution changes color or becomes cloudy.
Keep this and all medications out of the reach of children. In case of accidental ingestion, seek professional assistance or call a Poison Control Center immediately.
Tamper Evident: For your protection, this bottle has an imprinted seal around the neck. Do Not Use if seal is damaged or missing at time of purchase.
There are no adequate and well-controlled studies in pregnant women. FreshKote® should be used during pregnancy only if the potential benefit justifies the potential risk.
To report SUSPECTED ADVERSE REACTIONS, contact FOCUS Laboratories, Inc. at (501) 753-6006 8am-5pm Monday-Friday CST.
DOSAGE and ADMINISTRATION:
Instill 1 or 2 drop(s) in the affected eye(s) 3 or 4 times daily.
FreshKote® is packaged in 15 mL (NDC# 15821-101-15) and 1 mL (NDC# 15821-101-01) bottles; with a control dropper.
Store at controlled room temperature 15°-30°C (59°-86°F). See box or dropper bottle for Lot Number and Expiration Date.