Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Worcester | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment | No Intervention | Exposure to grass pollen only | |
| Artificial Tear Supplement | Active Comparator | Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 |
|
| Cold compress | Active Comparator | Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue |
|
| Anti-allergic Medication | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Tear Supplement | Other | artificial tear supplement (Hypromellose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 hour |
| 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 | 1 hour |
| Ocular Temperature | Ocular surface temperature will be measured with an infra-red camera | 1 hour |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Wolffsohn, PhD | Aston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Pollen and Aerobiology Unit | Worcester | WR2 6AJ | United Kingdom |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | No Treatment/Artificial Tear / Cold Compress / Pharmaceutical | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects underwent skin prick and bilateral conjunctival challenge tests to confirm systemic and ocular allergic sensitivity to grass pollen
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | Units on a scale | 1 hour |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Treatment | Exposure to grass pollen only |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof James Wolffsohn | Aston University | +44(0)1212044140 | j.s.w.wolffsohn@aston.ac.uk |
Not provided
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C053090 | epinastine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cold compress | Device | 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 |
|
|
| Anti-allergic Medication | Drug | 1 drop on single occasion after exposure to grass pollen |
|
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Cold Compress | Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel |
| OG003 | 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 ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | units on a scale | 1 hour |
|
|
|
| Primary | Ocular Temperature | Ocular surface temperature will be measured with an infra-red camera | Posted | Mean | Standard Deviation | degrees centrigrade | 1 hour |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Artificial Tear Supplement | Preservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 Non-Pharmaceutical Tear Supplement: artificial tear supplement (Hypromellose) | 0 | 18 | 0 | 18 |
| EG002 | Cold Compress | Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue Eye Gel Mask Blue placed over the closed eyes: Bag fill with temperature retention gel | 0 | 18 | 0 | 18 |
| EG003 | 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 ELESTAT® (epinastine HCl ophthalmic solution) 0.05%: 1 drop on single occasion after exposure to grass pollen | 0 | 11 | 0 | 11 |
Not provided
Not provided