Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01569191|
Recruitment Status : Completed
First Posted : April 3, 2012
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypersensitivity||Other: Artificial Tear Supplement Device: Cold compress Drug: Anti-allergic Medication||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Investigating the Efficacy of Artificial Tear Supplements and Cold Compresses for the Treatment of Seasonal Allergic Conjunctivitis|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||February 2013|
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: Artificial 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: Cold compress
Cold compress bag fill with temperature retention gel placed over closed eyes Sold by http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue
Other Name: 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: Anti-allergic Medication
1 drop on single occasion after exposure to grass pollen
Other Name: ELESTAT® (epinastine HCl ophthalmic solution) 0.05%
- Symptoms [ Time Frame: 1 hour ]Short questionnaire Ocular allergy symptomology was also measured using the eye symptom section from the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) on a 0 to 6 scale, with the summed score for itching, watering, swelling and soreness resulting in a summed score between 0 and 24. A higher score indicates a worse outcome (more severe symptoms)
- Ocular Redness [ Time Frame: 1 hour ]
Bulbar and limbal redness will be observed with a slit lamp biomicroscope and graded using a validated scale
• The 'Efron' grading scale consists of 5 pictures of eyes of increasing severity of blood vessels over the white of the eye, with the clinician selecting the image closest to what they observe on the patient (0 indicating a white eye and 4 a very irritated eye). There are no subscales
- Ocular Temperature [ Time Frame: 1 hour ]Ocular surface temperature will be measured with an infra-red camera
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569191
|National Pollen and Aerobiology Unit|
|Worcester, United Kingdom, WR2 6AJ|
|Principal Investigator:||James Wolffsohn, PhD||Aston University|