Efficient lipid delivery to human tear film using a salt-sensitive emulsion system

Abstract

A salt-free emulsion for the treatment of dry eye and other ocular conditions is disclosed which contains castor oil and does not contain olive oil which prolongs TBUT and provides superior comfort.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application Ser. Nos. 61 / 568,089, filed Dec. 7, 2011 and 61 / 625,401 filed Apr. 17, 2012, the disclosures of which are hereby incorporated in their entirety herein by reference.FIELD OF INVENTION[0002]The present invention is directed to artificial tears suitable for treating dry eye syndrome and other ocular conditions in a human or other mammal.BACKGROUND OF THE INVENTION[0003]Typical symptoms of keratoconjunctivitis or dry eye include feelings of dryness, burning, and a sandy-gritty eye sensation that can worsen during the day. Symptoms may also be described as itchy, scratchy, stingy or tired eyes. Other symptoms include pain, redness, a pulling sensation, and pressure behind the eye. The damage to the eye surface resulting from dry eye increases discomfort and sensitivity to bright light and both eyes usually are affected.[0004]Because blinking coats the eye with tears, symptoms...

AI Technical Summary

Benefits of technology

[0038]As used herein, the term “effective amount” or “effective dose” means an amount sufficient to achieve the desired result on the process or condition, and it accordingly will depend on the ingredient and the desired result. Nonetheless, once the desired effect is known, determining the effective amount is within the skill of a person skilled in the art.

[0039]“Formulation,”“composition,” and “preparation” as used herein are equivalent terms referring to a composition of matter suitable for pharmaceutical use (i.e., producing a therapeutic effect as well as possessing acceptable pharmacokinetic and toxicological properties).

Problems solved by technology

The damage to the eye surface resulting from dry eye increases discomfort and sensitivity to bright light and both eyes usually are affected.

Because blinking coats the eye with tears, symptoms are worsened by activities in which the rate of blinking is reduced due to prolonged use of the eyes.

However, if the condition is left untreated or becomes severe, it can produce complications that can cause eye damage, resulting in impaired vision or possibly in the loss of vision.

Having dry eyes for a prolonged period of time can lead to tiny abrasions on the surface of the eyes.

Some severe cases result in thickening of the corneal surface, corneal erosion, punctate keratopathy, epithelial defects, corneal ulceration, corneal neovascularization, corneal scarring, corneal thinning, and even corneal perforation.

An abnormality of any one of the three layers of tears which produces an unstable tear film, may result in symptoms of keratitis sicca.

Keratoconjunctivitis sicca is usually due to inadequate tear production.

The aqueous tear layer is affected, resulting in aqueous tear deficiency or lacrimal hyposecretion.

The lacrimal gland does not produce sufficient tears to keep the entire conjunctiva and cornea covered by a complete layer.

Keratoconjunctivitis sicca can also be caused by abnormal tear composition resulting in rapid evaporation or premature destruction of the tears.

In this condition, although the tear gland produces a sufficient amount of tears, the rate of evaporation of the tears is too rapid.

There is a loss of water from the tears that results in tears that are too “salty” or hypertonic.

As a result, the entire conjunctiva and cornea cannot be kept covered with a complete layer of tears during certain activities or in certain environments.

This is due to the fact that tear production decreases with age.

Diabetics are also at increased risk for dry eye.

Disorders of the eyelid can impair the complex blinking motion required to spread tears.

Dry eyes caused by these procedures usually disappear after several months.

Lubricating tear ointments can be used during the day, but they generally are used at bedtime due to poor vision after application.