Efficacy of the Chronic Application of Tear Formulations

Glasgow Caledonian University

Status: Unknown

Conditions: Dry Eye

Treatments: Drug: Next Generation Emulsion; Drug: Refresh Contacts; Drug: Refresh Dry Eye Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01384851

AG9965-004

Details and patient eligibility

About

The purpose of this study is to determine the therapeutic effect of the chronic application of eye-drops on tear evaporation rate in dry eye and normal subjects exposed to a condition of environmental stress. The effect will be studied in terms of changes in tear physiology and the inflammatory biomarkers on the ocular surface.

Full description

Environmentally induced dry eye is a condition which occurs in otherwise asymptomatic individuals in certain situations, for example with the use of computers, in overheated or air conditioned workplaces and in conditions of low humidity. The most common ocular complaints associated with these environments are burning, dryness, stinging, and grittiness. Although the exact cause of these symptoms is unknown, it is thought that increased tear evaporation rate due to low humidity plays a vital role. The changes in tear film physiology, which occurs in these environments, have traditionally been dealt with by the use of eye drops (particularly the highly viscous variety), which have been shown to be an effective therapeutic option in the treatment of environmental dry eye disease. Previous studies of the use of eye-drops of various formulations has shown improvements in tear physiology in mild to moderate dry eye patients with their use in both acute and chronic application protocols. In this study, an attempt was made to relate the effects on tear physiology induced by variations in environmental conditions to the beneficial effect produced by the use of eye-drops.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be between the ages of 18 and 79 years of age.
• Must understand and be able, willing and likely to fully comply with study procedures and restrictions.

Exclusion criteria

• Active ocular allergy
• Current contact lens wear
• Any topical ophthalmic drops within 1 week of initial screening visit.
• Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of initial screening visit.
• Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days initial of screening visit.
• Known hypersensitivity to any of the agents used in testing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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38 participants in 3 patient groups

Next Generation Emulsion

Experimental group

Description:

Next Generation Emulsion Multi-Dose Eye Drop (9963X) is a sterile, buffered, aqueous and emulsion topical ophthalmic product formulated for the relief of ocular surface irritation and symptoms of dryness. The Next Generation Emulsion 9963X formulation is an oil-in-water aqueous emulsion intended to replenish deficient aqueous and lipid components and stabilising the tear film.

Treatment:

Drug: Next Generation Emulsion

Refresh Dry Eye Therapy

Active Comparator group

Description:

A preserved multi-dose formulation for use in treating dry eye symptomatology. The key ingredients are Castor oil, Polysorbate 80, Carbomer 1342 and Glycerin. Refresh Dry Eye Therapy® Lubricant Eye Drops contains emulsified castor oil, which enhances the natural oily superficial tear layer on the ocular surface. By stabilizing and supplementing the lipid layer, castor oil may retard evaporation of surface moisture.

Treatment:

Drug: Refresh Dry Eye Therapy

Refresh Contacts

Active Comparator group

Description:

Solution contains carboxymethylcellulose sodium (carmellose), sodium chloride, boric acid, sodium borate, potassium chloride, calcium chloride, magnesium chloride, Purite®, sodium hydroxide, and purified water. This product is registered as a CE Mark medical device. Refresh Contacts Comfort drops providing soothing relief from tired, dry eyes. Although intended for contact lens wearers, the primary indication is for relief of dry eyes as is being studied in this investigation.

Treatment:

Drug: Refresh Contacts