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Manuka Eye Droops for Treatment of Allergy

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ClinicalTrials.gov Identifier: NCT03862053
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Toyos Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Manuka honey Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized, double-blind placebo controlled
Masking: Double (Participant, Investigator)
Masking Description: medications will be covered by blank labels
Primary Purpose: Treatment
Official Title: A Phase 4 Study to Assess the Clinical Efficacy and Safety of Manuka Eye Drops for Treatment of Allergy
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Manuka honey eyedrops
optimel manuka eyedrops 10 ml used as directed in a CAC (Conjunctival allergen challenge) study
Drug: Manuka honey
manuka eyedrops applied to the ocular surface
Other Name: optimel eyedrops

Placebo Comparator: Normal saline 0.9% eyedrops
sterile normal saline eyedrops used as directed in a CAC (conjunctival allergen challenge) study
Drug: Manuka honey
manuka eyedrops applied to the ocular surface
Other Name: optimel eyedrops




Primary Outcome Measures :
  1. Subject-assessed ocular itching [ Time Frame: 7 weeks ]
    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

  2. Investigator-assessed conjunctival hyperemia in both eyes at each visit [ Time Frame: 7 weeks ]
    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


Secondary Outcome Measures :
  1. investigator-assessed ciliary hyperemia [ Time Frame: 7 weeks ]
    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

  2. investigator assessed episcleral hyperemia [ Time Frame: 7 weeks ]
    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

  3. investigator-assessed chemosis [ Time Frame: 7 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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.

    -


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): NCT03862053


Contacts
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Contact: Madison Rupard 6153274015 mrupard@toyosclinic.com
Contact: Melissa Toyos, MD 6153274015 mtoyos@toyosclinic.com

Locations
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United States, Tennessee
Toyos Clinic Not yet recruiting
Germantown, Tennessee, United States, 38138
Contact: Madison Rupard, OD    615-327-4015    mrupard@toyosclinic.com   
Contact: Haylie Mulliniks, od    9016837255    hmulliniks@gmail.com   
Toyos Clinic Not yet recruiting
Nashville, Tennessee, United States, 37027
Contact: Madison Rupard    615-327-4015    mrupard@toyosclinic.com   
Contact: Melissa Toyos, MD    6153274015    mtoyos@toyosclinic.com   
Sponsors and Collaborators
Toyos Clinic

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Responsible Party: Toyos Clinic
ClinicalTrials.gov Identifier: NCT03862053     History of Changes
Other Study ID Numbers: TCOPTIMEL-2019
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If requested, data records without identifying patient information could be shared

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Toyos Clinic:
ocular allergy
allergy
manuka honey
anti-inflammatory

Additional relevant MeSH terms:
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Hypersensitivity
Conjunctivitis
Conjunctivitis, Allergic
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Ophthalmic Solutions
Pharmaceutical Solutions