Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis
|Ocular Allergy||Other: Non-Pharmaceutical Tear Supplement Device: Eye Gel Mask Blue placed over the closed eyes Drug: ELESTAT® (epinastine HCl ophthalmic solution) 0.05%||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Investigating the Efficacy of Artificial Tear Supplements and Cold Compresses for the Treatment of Seasonal Allergic Conjunctivitis|
- Symptoms [ Time Frame: 1 hour ]Short questionnaire
- Ocular redness [ Time Frame: 1 hour ]Bulbar and limbal redness will be observed with a slit lamp biomicroscope and graded using a validated scale
- Ocular Temperature [ Time Frame: 1 hour ]Ocular surface temperature will be measured with an infra-red camera
|Study Start Date:||March 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
No Intervention: No Treatment
Exposure to grass pollen only
Active Comparator: Artificial Tear Supplement
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006
Other: Non-Pharmaceutical Tear Supplement
artificial tear supplement (Hypromellose)
Other Name: Hypromellose is also sold as Isopto plain eye drops
Active Comparator: Cold Compress
Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue
Device: Eye Gel Mask Blue placed over the closed eyes
Bag fill with temperature retention gel
Other Name: Sold by http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue
Active Comparator: Anti-allergic Medication
ELESTAT® (epinastine HCl ophthalmic solution) 0.05% Initial U.S. Approval: 2003 H1 histamine receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis
Drug: ELESTAT® (epinastine HCl ophthalmic solution) 0.05%
1 drop on single occasion after exposure to grass pollen
There will be a total of 6 study visits, each lasting approximately 1 hour and separated by at least 2 days. At the beginning of each visit, a set of measurements will be taken by an experienced optometrist. These are:
- What symptoms you are feeling and how severe they are - you will be asked to complete a short questionnaire about how your eyes currently feel.
- The redness and temperature of your eyes - the front surface of both eyes will be photographed using digital cameras.
After these measurements we will ask you to stand inside a specially designed room where the environment can be controlled by a computer. The pollen that you were found to be allergic to will then be introduced into the atmosphere of the room, so that the signs and symptoms of SAC can be induced - this is intentional, but normally resolves within a few hours with no treatment. At each visit, you will experience a different duration (no longer than 10 minutes) and either no treatment, artificial tear supplement (ATS; preservative free ocular lubricant), cold compress (CC; cooled gel eye mask) or anti-allergic medication (epinastine hydrochloride 500μg/mL). The measurements will then be repeated even 5 minutes for an hour.
After the final set of measurements, the front surface of your eyes will be assessed using a temporary dye to highlight using a blue light any changes. Fluorescein dye does not sting, lasts only a few minutes and has no effect on vision or driving. However it may cause a self limiting mild allergic reaction where the eyes become red, irritated and sore but this is highly unlikely as there are no known reported cases. In the unlikely event this does happen the experienced optometrist is immediately available to manage the condition.
The anti-allergic drug epinastine hydrochloride (Elestat, Allergan) is a prescription only medicine indicated for the treatment of allergic conjunctivitis. As with all medications, there are potential side effects - although uncommon (1 in 10 to 1 in 100 people), there may be a slight burning sensation on application but this temporary and subsides quickly. The epinastine formulation also contains preservatives called benzalkonium chloride and disodium edetate. As with fluorescein sodium, these may cause a self limiting mild allergic reaction. In the unlikely event this does happen the experienced optometrist is immediately available to manage the condition.
Study Length and Reimbursement Each of the 6 measurement visits is separated by 7 days therefore the total study length for each participant is 6 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01569191
|National Pollen and Aerobiology Unit|
|Worcester, United Kingdom, WR2 6AJ|