Clinical trial NCT01384851: Efficacy of the Chronic Application of Tear Formulations
Official title: Therapeutic Efficacy of the Chronic Application of Tear Formulations for Dry Eye and Normal Subjects Under Conditions of Environmental Stress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-06-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Tear Film Evaporation
timeFrame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Secondary outcomes:
measure: Interferometry
timeFrame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
measure: Tear Film Osmolarity
timeFrame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
measure: Non-invasive tear break up time
timeFrame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
measure: Tear sampling and bio-marker analysis
timeFrame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
Study officials:
affiliation: Glasgow Caledonian University
name: Alan Tomlinson, DSc PhD
role: PRINCIPAL_INVESTIGATOR
References: