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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
Sponsor:
Collaborator:
University of Worcester
Information provided by (Responsible Party):
Aston University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypersensitivity Other: Artificial Tear Supplement Device: Cold compress Drug: Anti-allergic Medication Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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%


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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


  3. Ocular Temperature [ Time Frame: 1 hour ]
    Ocular surface temperature will be measured with an infra-red camera


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
National Pollen and Aerobiology Unit
Worcester, United Kingdom, WR2 6AJ
Sponsors and Collaborators
Aston University
University of Worcester
Investigators
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Principal Investigator: James Wolffsohn, PhD Aston University
More Information
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Responsible Party: Aston University
ClinicalTrials.gov Identifier: NCT01569191    
Other Study ID Numbers: Allergy12
First Posted: April 3, 2012    Key Record Dates
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018
Last Verified: July 2015
Keywords provided by Aston University:
Ocular allergy
Tear supplement
Cold compress
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Ophthalmic Solutions
Lubricant Eye Drops
 Epinastine
Anti-Allergic Agents
Pharmaceutical Solutions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs