Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis

NCT01569191 | Completed Phase 4 Results

• 1 other identifier: Allergy12
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypersensitivity

Keywords

Ocular allergy; Tear supplement; Cold compress

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

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

Other: Artificial Tear Supplement

Cold compress

ACTIVE COMPARATOR

Cooled gel eye mask http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue

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

Drug: Anti-allergic Medication

Interventions

Artificial Tear Supplement OTHER

artificial tear supplement (Hypromellose)

Also known as: Hypromellose is also sold as Isopto plain eye drops

Artificial Tear Supplement

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

Also known as: Eye-gel-mask-blue

Cold compress

Anti-allergic Medication DRUG

1 drop on single occasion after exposure to grass pollen

Also known as: ELESTAT® (epinastine HCl ophthalmic solution) 0.05%

Anti-allergic Medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of seasonal allergic conjunctivitis or seasonal allergic rhinoconjunctivitis (seasonal hay fever) that is not currently active.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aston University: lead
• University of Worcester: collaborator

Study Sites (1)

National Pollen and Aerobiology Unit

Worcester, WR2 6AJ, United Kingdom

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

epinastine

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Prof James Wolffsohn
• Organization: Aston University

j.s.w.wolffsohn@aston.ac.uk

+44(0)1212044140

Study Officials

• James Wolffsohn, PhD

  Aston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 3, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 5, 2018
• Results First Posted: February 5, 2018

Record last verified: 2015-07

Locations

GB (1)