Efficacy of the Chronic Application of Tear Formulations

Dry Eye Clinical Trial

Official title:

Therapeutic Efficacy of the Chronic Application of Tear Formulations for Dry Eye and Normal Subjects Under Conditions of Environmental Stress

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01384851
• Other study ID #: AG9965-004
• Status: Not yet recruiting
• Phase: N/A
• First received: June 23, 2011
• Last updated: June 30, 2011
• Start date: July 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2011
• Source: Glasgow Caledonian University
• Contact: Alan Tomlinson, DSc PhD
• Phone: 0044 141 331
• Email: A.Tomlinson[@]gcu.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye

Intervention

Drug:
• Next Generation Emulsion
One drop both eyes 4 times daily for two weeks
• Refresh Dry Eye Therapy
One drop both eyes four times daily for two weeks
• Refresh Contacts
One drop both eyes four times daily for two weeks

Locations

Country	Name	City	State
United Kingdom	Glasgow Caledonian University	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
Glasgow Caledonian University	Allergan

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear Film Evaporation	Tear film evaporation will be determined with a 'Servo-Med EP-Evaporimeter'. This measures the relative humidity and temperature at two sensors separated by a known distance, above the evaporative surface. The ocular surface evaporation will be calculated from measurements of fluid loss with the eyes open and closed while the subject sits with the eye covered by a modified goggle.	Each subject will be followed for the duration of the study, an expected average of 8-9 weeks	No
Secondary	Interferometry	The structure and quality of the tear film will be assessed by observing the interference fringes of the lipid layer. Interferometry facilitated with a miniature slow motion video will be used. The grading system developed previously in our laboratory will be utilised to grade the tear film distribution. This grading system classifies the tear film structure on the basis of the distribution of tears after a blink. Measurements are made while the subject sits quietly and looks into the lens of the device.	Each subject will be followed for the duration of the study, an expected average of 8-9 weeks	No
Secondary	Tear Film Osmolarity	Tear film osmolarity was measured using an 'OcuSense TearLab Osmometer'. This employs a single use, disposable test card mounted to a collection pen, to obtain a small sample of tear fluid by passive capillary action from the inferior-temporal tear meniscus. The measurement of the electrical impedance is carried out within the pen. The pen is then docked into the reader, which calculates and displays the osmolarity result.	Each subject will be followed for the duration of the study, an expected average of 8-9 weeks	No
Secondary	Non-invasive tear break up time	The 'HIR-CAL Grid' system based on a modified Bausch and Lomb keratometer will be used. The 'HIR-CAL Grid'will be focused on the pre-corneal tear film and the time before first distortion of the grid image will be recorded. This will indicate the non-invasive tear break up time. Three measurements will be taken while the subject is instructed to blink and then to hold the eye open while the examiner watches the reflection from the tear film, and the mean calculated.	Each subject will be followed for the duration of the study, an expected average of 8-9 weeks	No
Secondary	Tear sampling and bio-marker analysis	Approximately 1 µl of tears will be collected from the subject's eye using a sterile micropipette.; It will then be diluted in cytokine assay buffer and simultaneously analysed for biomarkers of ocular surface disease (cytokines) using the Luminex Beadlyte assay system. The bio-markers to be studied are included in the Human high sensitivity cytokine/chemokine kit (Millipore). These markers are associated with pro-inflammatory activation and have been previously studied in dry eye and other inflammatory conditions.	Each subject will be followed for the duration of the study, an expected average of 8-9 weeks	No