Back to resultsManuka Eye Droops for Treatment of Allergy
Primary Purpose
Allergic Conjunctivitis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Manuka honey
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring ocular allergy, allergy, manuka honey, anti-inflammatory
Eligibility Criteria
Inclusion Criteria:
- Subject is able to read, understand and sign and informed consent.
- Provision of signed and dated informed consent form and HIPPA authorization.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 10-85 years.
- 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.
- Normal eyelid anatomy
- BCVA of 20/100 or better in each eye and IOP 5-22 mmHg in both eyes.
- 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
- 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.
Willingness to avoid the use of disallowed medications and contact lenses for the duration of the clinical trial.
-
Exclusion Criteria:
- Have a known hypersensitivity or contraindication to the investigational product or their components.
- Unwilling to attend study visits.
- 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.
- Contact lens use within the week prior to screening
- Unwilling to discontinue contact lens use for the duration of the study
- Pregnancy or lactation
- Ocular surgery or eyelid surgery within 6 months prior to screening.
- Subjects must be unwilling to abstain from eyelash growth products containing prostaglandins for the duration of the trial.
- Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 6 months prior to Visit 1.
- Febrile illness within one week.
- Treatment with another investigational drug or other intervention within one month.
- Subjects with a history of herpetic keratitis.
- Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.
- Use of new prescription eyedrop within 30 days of screening
- Change in systemic medication within 30 days of screening
- Anticipated relocation or extensive travel outside the study site that may preclude compliance with follow up visits over the study period
Did not meet CAC requirements at both Visits 1 and 2.
-
Sites / Locations
- Toyos Clinic
- Toyos Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Manuka honey eyedrops
Normal saline 0.9% eyedrops
Arm Description
optimel manuka eyedrops 10 ml used as directed in a CAC (Conjunctival allergen challenge) study
sterile normal saline eyedrops used as directed in a CAC (conjunctival allergen challenge) study
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03862053
Brief Title
Manuka Eye Droops for Treatment of Allergy
Official Title
A Phase 4 Study to Assess the Clinical Efficacy and Safety of Manuka Eye Drops for Treatment of Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
not enough time to complete trial;covid
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
October 7, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Toyos Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
ocular allergy, allergy, manuka honey, anti-inflammatory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind placebo controlled
Masking
ParticipantInvestigator
Masking Description
medications will be covered by blank labels
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manuka honey eyedrops
Arm Type
Active Comparator
Arm Description
optimel manuka eyedrops 10 ml used as directed in a CAC (Conjunctival allergen challenge) study
Arm Title
Normal saline 0.9% eyedrops
Arm Type
Placebo Comparator
Arm Description
sterile normal saline eyedrops used as directed in a CAC (conjunctival allergen challenge) study
Intervention Type
Drug
Intervention Name(s)
Manuka honey
Other Intervention Name(s)
optimel eyedrops
Intervention Description
manuka eyedrops applied to the ocular surface
Primary Outcome Measure Information:
Title
Subject-assessed ocular itching
Description
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
Title
Investigator-assessed conjunctival hyperemia in both eyes at each visit
Description
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 Outcome Measure Information:
Title
investigator-assessed ciliary hyperemia
Description
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
Title
investigator assessed episcleral hyperemia
Description
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
Title
investigator-assessed chemosis
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is able to read, understand and sign and informed consent.
Provision of signed and dated informed consent form and HIPPA authorization.
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 10-85 years.
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.
Normal eyelid anatomy
BCVA of 20/100 or better in each eye and IOP 5-22 mmHg in both eyes.
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
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.
Willingness to avoid the use of disallowed medications and contact lenses for the duration of the clinical trial.
-
Exclusion Criteria:
Have a known hypersensitivity or contraindication to the investigational product or their components.
Unwilling to attend study visits.
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.
Contact lens use within the week prior to screening
Unwilling to discontinue contact lens use for the duration of the study
Pregnancy or lactation
Ocular surgery or eyelid surgery within 6 months prior to screening.
Subjects must be unwilling to abstain from eyelash growth products containing prostaglandins for the duration of the trial.
Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 6 months prior to Visit 1.
Febrile illness within one week.
Treatment with another investigational drug or other intervention within one month.
Subjects with a history of herpetic keratitis.
Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance.
Use of new prescription eyedrop within 30 days of screening
Change in systemic medication within 30 days of screening
Anticipated relocation or extensive travel outside the study site that may preclude compliance with follow up visits over the study period
Did not meet CAC requirements at both Visits 1 and 2.
-
Facility Information:
Facility Name
Toyos Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Toyos Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
If requested, data records without identifying patient information could be shared
Learn more about this trial
Manuka Eye Droops for Treatment of Allergy
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