Phase
Condition
Hives (Urticaria)
Skin Wounds
Rash
Treatment
Lumify®
BTOS-HA
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntarily provide written informed consent
≥18 years of age
Able and willing to follow instructions, including participation in all trialassessments and visits
History of vasoconstrictor (redness relief drops) use within the last 6 months, or adesire to use over the counter (OTC) vasoconstrictors for redness relief
Able to self-administer eye drops satisfactorily
A calculated best-corrected (if necessary) visual acuity of 0.3 logarithm of theminimum angle of resolution (logMAR) or better in each eye, as measured using anEarly Treatment Diabetic Retinopathy Study (ETDRS) chart
Show a baseline redness score >1 in both eyes as scored by the investigator usingthe Investigator Ocular Redness Scale (range 0-4)
Stable ocular health at Visit 2 (Day 1), (defined as no ocular conditions requiringtherapy or surgical intervention during the study).
Exclusion
Exclusion Criteria:
Known contraindications or sensitivity to the use of any of the investigationaldrug(s) or their components, or any other medications required by the protocol
Ocular surgery within 3 months prior to screening and/or a history of refractivesurgery within the past 6 months, and/ or planned surgery (ocular or systemic)during the trial period or within 30 days after the study period
Have the presence of an active ocular infection (bacterial, viral, or fungal) orpositive history of an ocular herpetic infection
Use any of the following disallowed medications during the period indicated prior torandomization or planned use during the study:
All topical ophthalmic agents including artificial tear products, eye whiteners (e.g., vasoconstrictors), ocular decongestants, ocular antihistamines, ocularcorticosteroids, dilating drops (excluding dilated ophthalmoscopy exam at Visit 2), and contact lenses: 5 days
Systemic antihistamines or decongestants: 7 days
Systemic corticosteroids or cancer chemotherapy, and/or any other systemicmedications which the investigator feels may confound study data, put thesubject at risk or interfere with subject's study participation: 14 days
Have prior (within 7 days of beginning investigational drug) or currently activesignificant illness that could compromise participation, in the opinion of theinvestigator
Have prior (within 30 days of beginning investigational drug) or anticipatedconcurrent use of an investigational drug or device during the study period
Have an ocular or systemic condition or a situation which, in the investigator'sopinion, may put the subject at increased risk, confound study data, or interferesignificantly with the subject's study participation (e.g., blepharitis, activeocular allergies, rosacea with peri-ocular involvement, uncontrolled diabetes,hypertension, or cardiovascular disease).
Have a diagnosis of ocular hypertension or glaucoma at screening
Any female who is nursing, lactating, pregnant, planning a pregnancy, or has apositive urine pregnancy test at Visit 2 (Day 1).
Any female of childbearing potential (FOCBP) who is unwilling to: a) agree to haveurine pregnancy testing performed at Visit 2 (Day 1), and b) agree to use at least 1medically acceptable form of birth control for at least 14 days prior to the firstdose of study drug at Visit 2 (Day 1), throughout the study duration, and for 1month after the last dose of investigational drug at Visit 4 (Day 29) NOTE: FOCBPinclude all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have notundergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,or bilateral oophorectomy) NOTE: Acceptable forms of birth control include:
Mechanical (spermicide in conjunction with a barrier such as a diaphragm orcondom)
Hormonal contraceptive (oral, injectable, implantable, or transdermal)
Intrauterine device, or
Surgical sterilization of male partner at least 3 months prior to the firstdose of investigational drug at Visit 2 (Day 1) NOTE: For non-sexually active female subjects, abstinence may be regarded as anadequate method of birth control when this is in line with the preferred and usuallifestyle of the subject; however, if the subject becomes sexually active during thetrial, she must agree to use adequate birth control as defined above for theremainder of the trial
- Any male who is unwilling to agree to use at least 1 medically acceptable form ofbirth control with female partner (FOCBP)
NOTE: Acceptable forms of birth control include:
True abstinence (when this is in line with the preferred and usual lifestyle of thesubject), or
Vasectomy at least 3 months prior to the first dose of study drug at Visit 2 (Day 1)
Without a vasectomy, must use condoms with spermicidal foam/gel/film/cream/suppository at least 14 days prior to the first dose of investigational drug at Visit 2 (Day 1) and throughout the study duration, and for 1 month after the last dose of the investigational drug at Visit 4 (Day 29)
Study Design
Connect with a study center
Site 102
Glendale, California 91204
United StatesActive - Recruiting
Site 103
Newport Beach, California 92663
United StatesActive - Recruiting
Site 105
Garner, North Carolina 27529
United StatesActive - Recruiting
Site 104
Shelby, North Carolina 28150
United StatesActive - Recruiting
Site 101
Memphis, Tennessee 38119
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.