Allergic ConjunctivitisPhase 4NCT03862053
Manuka Eye Droops for Treatment of Allergy
A Phase 4 study testing Manuka honey in people with Allergic Conjunctivitis, run by Toyos Clinic at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Manuka honey
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2020to 7 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- -
Who cannot join
- 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
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- 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.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Toyos Clinic
Germantown, Tennessee, 38138
Toyos Clinic
Nashville, Tennessee, 37027
About this study
Official title: A Phase 4 Study to Assess the Clinical Efficacy and Safety of Manuka Eye Drops for Treatment of Allergy
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.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Manuka honey
- Keywords
- ocular allergy, allergy, manuka honey, anti-inflammatory
- Medical subject headings
- Conjunctivitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka honeyDrug
Also called optimel eyedrops
manuka eyedrops applied to the ocular surface
| Study group | Role | What they receive |
|---|---|---|
| Manuka honey eyedrops | Active comparator | optimel manuka eyedrops 10 ml used as directed in a CAC (Conjunctival allergen challenge) study Receives: Drug: Manuka honey |
| Normal saline 0.9% eyedrops | Placebo comparator | sterile normal saline eyedrops used as directed in a CAC (conjunctival allergen challenge) study Receives: Drug: Manuka honey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start1 Jan 2020 (estimated)
- Primary completion7 Oct 2020
- Study completion7 Oct 2020 (estimated)
Why it stopped: not enough time to complete trial;covid
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toyos Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862053
- Sponsor's protocol ID
- TCOPTIMEL-2019
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2019
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If requested, data records without identifying patient information could be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Study to Assess the Clinical Efficacy and Safety of Manuka Eye Drops for Treatment of Allergy
- ClinicalTrials.gov ID
- NCT03862053
- Acronym / sponsor ID
- TCOPTIMEL-2019
- Conditions
- Allergic Conjunctivitis
- Keywords
- ocular allergy, allergy, manuka honey, anti-inflammatory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not enough time to complete trial;covid
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Toyos ClinicUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (estimated)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Manuka honey eyedrops | Active comparator | Drug: Manuka honeyoptimel manuka eyedrops 10 ml used as directed in a CAC (Conjunctival allergen challenge) study |
| Normal saline 0.9% eyedrops | Placebo comparator | Drug: Manuka honeysterile normal saline eyedrops used as directed in a CAC (conjunctival allergen challenge) study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manuka honeyAlso: optimel eyedropsmanuka eyedrops applied to the ocular surface | Drug | Manuka honey eyedrops, Normal saline 0.9% eyedrops |
Primary outcome
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
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
3 secondary outcomes
investigator-assessed ciliary hyperemia
Time frame: 7 weeks
investigator assessed episcleral hyperemia
Time frame: 7 weeks
investigator-assessed chemosis
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: Undecided. If requested, data records without identifying patient information could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Manuka honey in people with Allergic Conjunctivitis, run by Toyos Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject-assessed ocular itching (time frame: 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.