Manuka Eye Droops for Treatment of Allergy

NCT03862053 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: TCOPTIMEL-2019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Allergic Conjunctivitis

Keywords

ocular allergy; allergy; manuka honey; anti-inflammatory

Outcome Measures

Primary Outcomes (2)

• 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

  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

  7 weeks

Secondary Outcomes (3)

• investigator-assessed ciliary hyperemia

  7 weeks

• investigator assessed episcleral hyperemia

  7 weeks

• investigator-assessed chemosis

  7 weeks

Study Arms (2)

Manuka honey eyedrops

ACTIVE COMPARATOR

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

Drug: Manuka honey

Normal saline 0.9% eyedrops

PLACEBO COMPARATOR

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

Drug: Manuka honey

Interventions

Manuka honey DRUG

manuka eyedrops applied to the ocular surface

Also known as: optimel eyedrops

Manuka honey eyedrops; Normal saline 0.9% eyedrops

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Toyos Clinic: lead

Study Sites (2)

Toyos Clinic

Germantown, Tennessee, 38138, United States

Location

Toyos Clinic

Nashville, Tennessee, 37027, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: medications will be covered by blank labels
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind placebo controlled

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 5, 2019
• Study Start: January 1, 2020
• Primary Completion: October 7, 2020
• Study Completion: October 7, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

US (2)