Efficacy of the Chronic Application of Tear Formulations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Glasgow Caledonian University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
Glasgow Caledonian University
ClinicalTrials.gov Identifier:
NCT01384851
First received: June 23, 2011
Last updated: June 30, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Dry Eye
Drug: Next Generation Emulsion
Drug: Refresh Dry Eye Therapy
Drug: Refresh Contacts

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy of the Chronic Application of Tear Formulations for Dry Eye and Normal Subjects Under Conditions of Environmental Stress

Further study details as provided by Glasgow Caledonian University:

Primary Outcome Measures:
  • Tear Film Evaporation [ Time Frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Interferometry [ Time Frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks ] [ Designated as safety issue: No ]
    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.

  • Tear Film Osmolarity [ Time Frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks ] [ Designated as safety issue: No ]
    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.

  • Non-invasive tear break up time [ Time Frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks ] [ Designated as safety issue: No ]
    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.

  • Tear sampling and bio-marker analysis [ Time Frame: Each subject will be followed for the duration of the study, an expected average of 8-9 weeks ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 38
Study Start Date: July 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Next Generation Emulsion
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.
Drug: Next Generation Emulsion
One drop both eyes 4 times daily for two weeks
Other Name: Next Generation Emulsion
Active Comparator: Refresh Dry Eye Therapy
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.
Drug: Refresh Dry Eye Therapy
One drop both eyes four times daily for two weeks
Other Name: Refresh Dry Eye Therapy
Active Comparator: Refresh Contacts
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.
Drug: Refresh Contacts
One drop both eyes four times daily for two weeks
Other Name: Refresh Contacts

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

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384851

Contacts
Contact: Alan Tomlinson, DSc PhD 0044 141 331 ext 3380 A.Tomlinson@gcu.ac.uk

Locations
United Kingdom
Glasgow Caledonian University
Glasgow, United Kingdom, G4 0BA
Sponsors and Collaborators
Glasgow Caledonian University
Allergan
Investigators
Principal Investigator: Alan Tomlinson, DSc PhD Glasgow Caledonian University
  More Information

No publications provided

Responsible Party: Alan Tomlinson, Glasgow Caledonian University
ClinicalTrials.gov Identifier: NCT01384851     History of Changes
Other Study ID Numbers: AG9965-004
Study First Received: June 23, 2011
Last Updated: June 30, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014