Status:
WITHDRAWN
Manuka Eye Droops for Treatment of Allergy
Lead Sponsor:
Toyos Clinic
Conditions:
Allergic Conjunctivitis
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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-inflammato...
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 blurr...
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 7 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03862053
Start Date
January 1 2020
End Date
October 7 2020
Last Update
October 9 2020
Active Locations (2)
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1
Toyos Clinic
Germantown, Tennessee, United States, 38138
2
Toyos Clinic
Nashville, Tennessee, United States, 37027