Manuka Eye Droops for Treatment of Allergy

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Allergic Conjunctivitis

In brief

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.

Key facts

Study ID

NCT03862053

Run by

Toyos Clinic

People needed

0

Starts

2020-01-01

Expected to finish

2020-10-07

Last updated by the study team

2020-10-09

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• Toyos Clinic — Germantown, Tennessee, United States
• Toyos Clinic — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.