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Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis

Investigating the Efficacy of Artificial Tear Supplements and Cold Compresses for the Treatment of Seasonal Allergic Conjunctivitis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01569191
Enrollment
18
Registered
2012-04-03
Start date
2012-03-31
Completion date
2013-02-28
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity

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

OTHERArtificial Tear Supplement

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

DRUGAnti-allergic Medication

1 drop on single occasion after exposure to grass pollen

Sponsors

University of Worcester
CollaboratorOTHER
Aston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Symptoms1 hourShort 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 Redness1 hourBulbar 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 Temperature1 hourOcular surface temperature will be measured with an infra-red camera

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
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
Total18

Baseline characteristics

CharacteristicNo Treatment / Artificial Tear / Cold CompressNo Treatment / Artificial Tear / Cold Compress / PharmaceuticaTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
11 Participants7 Participants18 Participants
Age, Continuous29.4 years
STANDARD_DEVIATION 10.7
29.5 years
STANDARD_DEVIATION 11
29.5 years
STANDARD_DEVIATION 11
Region of Enrollment
United Kingdom
11 participants7 participants18 participants
Sex: Female, Male
Female
7 Participants2 Participants9 Participants
Sex: Female, Male
Male
4 Participants5 Participants9 Participants

Adverse events

Event typeEG000
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 / 180 / 180 / 180 / 11
serious
Total, serious adverse events
0 / 180 / 180 / 180 / 11

Outcome results

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

Time frame: 1 hour

ArmMeasureValue (MEAN)Dispersion
No TreatmentOcular Redness2.15 units on a scaleStandard Deviation 0.4
Artificial Tear SupplementOcular Redness1.79 units on a scaleStandard Deviation 0.4
Cold CompressOcular Redness1.61 units on a scaleStandard Deviation 0.32
Anti-allergic MedicationOcular Redness1.78 units on a scaleStandard Deviation 0.38
Primary

Ocular Temperature

Ocular surface temperature will be measured with an infra-red camera

Time frame: 1 hour

ArmMeasureValue (MEAN)Dispersion
No TreatmentOcular Temperature35.88 degrees centrigradeStandard Deviation 0.75
Artificial Tear SupplementOcular Temperature35.91 degrees centrigradeStandard Deviation 0.96
Cold CompressOcular Temperature35.41 degrees centrigradeStandard Deviation 0.88
Anti-allergic MedicationOcular Temperature34.56 degrees centrigradeStandard Deviation 0.85
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)

Time frame: 1 hour

ArmMeasureValue (MEAN)Dispersion
No TreatmentSymptoms15.3 Units on a scaleStandard Deviation 1.8
Artificial Tear SupplementSymptoms11.3 Units on a scaleStandard Deviation 1.2
Cold CompressSymptoms13.3 Units on a scaleStandard Deviation 1.1
Anti-allergic MedicationSymptoms9.8 Units on a scaleStandard Deviation 1.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026