Phase 4
N=18
Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis
Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT01569191 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Symptoms — 15.3; 11.3; 13.3; 9.8 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Artificial Tear Supplement (Other); Cold compress (Device); Anti-allergic Medication (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aston University
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptoms |
15.3; 11.3; 13.3; 9.8 | — |
| PRIMARY Ocular Redness |
2.15; 1.79; 1.61; 1.78 | — |
| PRIMARY Ocular Temperature |
35.88; 35.91; 35.41; 34.56 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01569191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.