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WithdrawnNCT03862053Updated Oct 9, 2020

Manuka Eye Droops for Treatment of Allergy

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 Withdrawn at 2 sites in United States.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

Why this study was withdrawn
not enough time to complete trial;covid
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Allergic Conjunctivitis

Keywords

  • ocular allergy
  • allergy
  • manuka honey
  • anti-inflammatory
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

Browse Conjunctivitis studies →

Lead sponsor

Toyos Clinic is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subject is able to read, understand and sign and informed consent.
  2. Provision of signed and dated informed consent form and HIPPA authorization.
  3. Stated willingness to comply with all study procedures and availability for the duration of the study
  4. Male or female, aged 10-85 years.
  5. Positive bilateral CAC reaction (> or = to 2 units itching and > or = to 2 units redness in two of three vessel beds) within 10 minutes of instillation of the last allergen titration at visit 1 and a similarly positive bilateral CAC reaction at two or more time points at visit 2.
  6. Normal eyelid anatomy
  7. BCVA of 20/100 or better in each eye and IOP 5-22 mmHg in both eyes.
  8. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of study drug administration
  9. Are postmenopausal (no menstrual cycle for at least one year prior to Visit 1) or have undergone bilateral tubal ligation, hysterectomy, hysterectomy with uni- or bilateral oophorectomy, or bilateral oophorectomy.
  10. Willingness to avoid the use of disallowed medications and contact lenses for the duration of the clinical trial.

Exclusion criteria

-

Exclusion Criteria:

  1. Have a known hypersensitivity or contraindication to the investigational product or their components.
  2. Unwilling to attend study visits.
  3. Active ocular disease or significant illness (clinically significant blepharitis, uncontrolled cardiovascular disease, narrow-angle glaucoma) that could affect their safety or the parameters of the study.
  4. Contact lens use within the week prior to screening
  5. Unwilling to discontinue contact lens use for the duration of the study
  6. Pregnancy or lactation
  7. Ocular surgery or eyelid surgery within 6 months prior to screening.
  8. Subjects must be unwilling to abstain from eyelash growth products containing prostaglandins for the duration of the trial.
  9. Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 6 months prior to Visit 1.
  10. Febrile illness within one week.
  11. Treatment with another investigational drug or other intervention within one month.
  12. Subjects with a history of herpetic keratitis.
  13. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.
  14. Use of new prescription eyedrop within 30 days of screening
  15. Change in systemic medication within 30 days of screening
  16. Anticipated relocation or extensive travel outside the study site that may preclude compliance with follow up visits over the study period
  17. Did not meet CAC requirements at both Visits 1 and 2.

    -

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Manuka honey eyedrops

    optimel manuka eyedrops 10 ml used as directed in a CAC (Conjunctival allergen challenge) study

    Drug: Manuka honey

  • Placebo comparator
    Normal saline 0.9% eyedrops

    sterile normal saline eyedrops used as directed in a CAC (conjunctival allergen challenge) study

    Drug: Manuka honey

Interventions

  • DrugManuka honey

    manuka eyedrops applied to the ocular surface

    Also known as: optimel eyedrops

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

2 sites
  • Toyos Clinic
    Germantown, Tennessee 38138, United States
  • Toyos Clinic
    Nashville, Tennessee 37027, United States
08

References and documents

Individual participant data

Plan to share: Undecided — If requested, data records without identifying patient information could be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03862053
Lead sponsor
Toyos Clinic
Responsible party
Sponsor
First posted
Mar 5, 2019
Start date
Jan 1, 2020 (estimated)
Primary completion
Oct 7, 2020
Completion
Oct 7, 2020 (estimated)
Last update
Oct 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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