A Phase 4 interventional study of Manuka honey in Allergic Conjunctivitis, sponsored by Toyos Clinic. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-10-09.
Sponsored by Toyos Clinic · Phase 4, Interventional, and Treatment
Manuka honey eye drops are used for dry eyes and blepharitis. Manuka honey has been proven to be useful for eczema, atopic dermatitis, wound healing, anti-bacterial, anti-parasitic and anti-inflammatory actions.
Ocular allergy is a condition that can affect a patient's quality of life. Symptoms of ocular allergy include but are not limited to red, itchy, swollen, foreign body sensation, watery, puffy or blurry eyes. irritation, redness, burning, foreign body sensation, dryness, pain and blurry vision. In many cases, ocular allergic conjunctivitis are due to seasonal allergens like pollen, mold or indoor allergens such as pet dander or dust mites.
Ocular allergy can be treated by avoidance of known allergens, reduction of allergens by use of HEPA filters, cleaning linens, etc, topical decongestants, over the counter and prescription topical non-steroidals, topical or oral antihistamines, mast cell stabilizers or topical or oral steroids.
Manuka honey is produced by bees that are associated with the flowers of the Manuka plant (Leptospermum scoparium) that grows in New Zealand. Manuka honey is different from other honeys because it has been shown to the more potent due to its higher methylglyoxal concentration.
Manuka honey has been used for its anti-oxidant, anti-bacteral and anti-inflammatory properties. It has been shown to be useful in healing eczematous skin lesions. This study will attempt to demonstrate topical anti-allergy use for ocular allergy.
361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.
Browse Conjunctivitis studies →Toyos Clinic is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Did not meet CAC requirements at both Visits 1 and 2.
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optimel manuka eyedrops 10 ml used as directed in a CAC (Conjunctival allergen challenge) study
Drug: Manuka honey
sterile normal saline eyedrops used as directed in a CAC (conjunctival allergen challenge) study
Drug: Manuka honey
manuka eyedrops applied to the ocular surface
Also known as: optimel eyedrops
Subject-assessed ocular itching
on a scale from 0-100 where 0 =no itching and 100=maximal itching subtracted scores measured for placebo treatments at visits 3B, 4 and 5
Time frame: 7 weeks
Investigator-assessed conjunctival hyperemia in both eyes at each visit
on a scale from 0-100 where 0=no hyperemia and 100=maximal hyperemia subtracted scores from placebo treatments at visits 3B, 4 and 5
Time frame: 7 weeks
investigator-assessed ciliary hyperemia
on a scale from 0-100 where 0=no hyperemia and 100=maximal hyperemia subtracted scores from placebo treatments at visits 3B, 4 and 5
Time frame: 7 weeks
investigator assessed episcleral hyperemia
on a scale from 0-100 where 0=no hyperemia and 100=maximal hyperemia subtracted scores from placebo treatments at visits 3B, 4 and 5
Time frame: 7 weeks
investigator-assessed chemosis
on a scale from 0-100 where 0=no hyperemia and 100=maximal hyperemia subtracted scores from placebo treatments at visits 3B, 4 and 5
Time frame: 7 weeks
Plan to share: Undecided — If requested, data records without identifying patient information could be shared
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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