HypersensitivityPhase 4NCT01569191
Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis
A Phase 4 study testing Artificial Tear Supplement, Cold compress and Anti-allergic Medication in people with Hypersensitivity, run by Aston University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- Artificial Tear Supplement, Cold compress and Anti-allergic Medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Feb 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of seasonal allergic conjunctivitis or seasonal allergic rhinoconjunctivitis (seasonal hay fever) that is not currently active.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Pollen and Aerobiology Unit
Worcester, WR2 6AJ
About this study
Official title: Investigating the Efficacy of Artificial Tear Supplements and Cold Compresses for the Treatment of Seasonal Allergic Conjunctivitis
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.
Read the 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.
- Conditions
- Hypersensitivity
- Being tested
- Artificial Tear Supplement, Cold compress, Anti-allergic Medication
- Keywords
- Ocular allergy, Tear supplement, Cold compress
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Tear SupplementOther
Also called Hypromellose is also sold as Isopto plain eye drops
artificial tear supplement (Hypromellose)
Cold compressDevice
Also called Eye-gel-mask-blue
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 MedicationDrug
Also called ELESTAT® (epinastine HCl ophthalmic solution) 0.05%
1 drop on single occasion after exposure to grass pollen
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Artificial Tear Supplement |
| Cold compress | Active comparator | Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue Receives: Device: Cold compress |
| 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 Receives: Drug: Anti-allergic Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1 hour
Ocular Temperature
Ocular surface temperature will be measured with an infra-red camera
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Worcester
- Responsible party
- Sponsor
- Investigators
- James Wolffsohn, PhD, Principal investigator, Aston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569191
- Sponsor's protocol ID
- Allergy12
- Status last verified
- Jul 2015
- First submitted
- 27 Mar 2012
- Last updated
- 5 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Artificial Tear Supplements and Cold Compresses for the Treatment of Seasonal Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01569191
- Acronym / sponsor ID
- Allergy12
- Conditions
- Hypersensitivity
- Keywords
- Ocular allergy, Tear supplement, Cold compress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Collaborators
- University of Worcester
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Posted 5 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Treatment | No intervention | –Exposure to grass pollen only |
| Artificial Tear Supplement | Active comparator | Other: Artificial Tear SupplementPreservative free Hypromellose Eye Drops BP 0.3% w/v preservative free - MHRA product licence number:23097/0006 |
| Cold compress | Active comparator | Device: Cold compressCooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue |
| Anti-allergic Medication | Active comparator | Drug: Anti-allergic MedicationELESTAT® (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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- history of seasonal allergic conjunctivitis or seasonal allergic rhinoconjunctivitis (seasonal hay fever) that is not currently active.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Tear SupplementAlso: Hypromellose is also sold as Isopto plain eye dropsartificial tear supplement (Hypromellose) | Other | Artificial Tear Supplement |
| Cold compressAlso: Eye-gel-mask-blueCold compress bag fill with temperature retention gel placed over closed eyes Sold by http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue | Device | Cold compress |
| Anti-allergic MedicationAlso: ELESTAT® (epinastine HCl ophthalmic solution) 0.05%1 drop on single occasion after exposure to grass pollen | Drug | Anti-allergic Medication |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypersensitivity
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Wolffsohn, PhD principal investigator
Aston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artificial Tear Supplement, Cold compress and Anti-allergic Medication in people with Hypersensitivity, run by Aston University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.