Hypersensitivity
Conditions
Keywords
Ocular allergy, Tear supplement, Cold compress
Brief summary
Seasonal allergic conjunctivitis (SAC) is an irritating eye condition that affects many people, caused by hypersensitivity to normally harmless substances such as pollen, and often accompanies seasonal hay fever. Treatments that can be used before initiating medical therapy include artificial tear supplements (ATS) and cold compresses (CC). However, there is no evidence in the scientific literature that demonstrates their efficacy compared to no treatment or their combined effect with anti-allergic medication. Therefore the investigators aim to examine the efficacy of ATS and CC alone, in comparison to anti-allergic medication, and CC in combination with anti-allergic medication. In addition, the investigators also aim to determine the time course of ocular allergic reactions. At the end of the study the investigators will be able to see whether or not ATS and CC are effective in treating SAC.
Detailed description
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.
Interventions
artificial tear supplement (Hypromellose)
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
1 drop on single occasion after exposure to grass pollen
Sponsors
Study design
Eligibility
Inclusion criteria
* history of seasonal allergic conjunctivitis or seasonal allergic rhinoconjunctivitis (seasonal hay fever) that is not currently active.
Exclusion criteria
* eye surgery in the last 3 months * active eye condition * adverse reaction to ocular drugs or dyes * history of anaphylaxis (severe systemic allergic reaction) * use any ocular medication or systemic medications (antihistamines, mast cell stabilisers, non-steroidal anti-inflammatory drugs or steroids) at least 14 days prior to the start and for the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms | 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 | 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 | 1 hour | Ocular surface temperature will be measured with an infra-red camera |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Treatment / Artificial Tear / Cold Compress / Pharmaceutica Exposure to grass pollen only
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear
Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel
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
ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen | 7 |
| No Treatment / Artificial Tear / Cold Compress Exposure to grass pollen only
Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement artificial tear
Cooled gel eye mask http://www.visiondirect.co.uk/visiondirect/ eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel | 11 |
| Total | 18 |
Baseline characteristics
| Characteristic | No Treatment / Artificial Tear / Cold Compress | No Treatment / Artificial Tear / Cold Compress / Pharmaceutica | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 7 Participants | 18 Participants |
| Age, Continuous | 29.4 years STANDARD_DEVIATION 10.7 | 29.5 years STANDARD_DEVIATION 11 | 29.5 years STANDARD_DEVIATION 11 |
| Region of Enrollment United Kingdom | 11 participants | 7 participants | 18 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 11 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 11 |
Outcome results
Ocular Redness
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
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Ocular Redness | 2.15 units on a scale | Standard Deviation 0.4 |
| Artificial Tear Supplement | Ocular Redness | 1.79 units on a scale | Standard Deviation 0.4 |
| Cold Compress | Ocular Redness | 1.61 units on a scale | Standard Deviation 0.32 |
| Anti-allergic Medication | Ocular Redness | 1.78 units on a scale | Standard Deviation 0.38 |
Ocular Temperature
Ocular surface temperature will be measured with an infra-red camera
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Ocular Temperature | 35.88 degrees centrigrade | Standard Deviation 0.75 |
| Artificial Tear Supplement | Ocular Temperature | 35.91 degrees centrigrade | Standard Deviation 0.96 |
| Cold Compress | Ocular Temperature | 35.41 degrees centrigrade | Standard Deviation 0.88 |
| Anti-allergic Medication | Ocular Temperature | 34.56 degrees centrigrade | Standard Deviation 0.85 |
Symptoms
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)
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Symptoms | 15.3 Units on a scale | Standard Deviation 1.8 |
| Artificial Tear Supplement | Symptoms | 11.3 Units on a scale | Standard Deviation 1.2 |
| Cold Compress | Symptoms | 13.3 Units on a scale | Standard Deviation 1.1 |
| Anti-allergic Medication | Symptoms | 9.8 Units on a scale | Standard Deviation 1.3 |