Phase
Condition
N/ATreatment
LEV102 1.0%
LEV102 2.0%
Vehicle
Clinical Study ID
Ages 25-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects who meet all the following inclusion criteria will be eligible to participate in the study. Subjects must:
- Be male or female subjects 25 years of age or older at the time of Screening (Visit
Have complaints of aesthetically unacceptable upper eyelid position for both eyesmaking them desirous for elevation, or have complaints of superior visual fielddefects in both eyes that impact activities of daily living
Present with the following at Screening (Visit 1): a. At least one eye that meets both of the following criteria: i. Margin ReflexDistance 1 MRD1 ≤2 mm (no visible central pupillary light reflex defaults to 0) ii.Current corrected VA, using subject's own prescription eyeglasses, if applicable, inthe qualifying eye(s) of +0.3 LogMAR (Logarithm of the Minimum Angle of Resolution)or better as assessed by ETDRS b. Demonstrate upper eyelid elevation ≥0.5 mm changefrom baseline in MRD1 in both eyes in response to a single drop of oxymetazoline 0.1% ophthalmic solution)to each eye at Screening
Women of Childbearing Potential must agree to use an approved method of birthcontrol from the date they sign the informed consent form (ICF) until after the laststudy visit (Follow-Up Visit)
Be able to give informed consent and willing to comply with all study visits andexaminations
Exclusion
Exclusion Criteria:
Have any other ocular pathology other than ptosis requiring treatment with topicalprescription ophthalmic drops in either eye (e.g., glaucoma, dry eye)
Have narrow angles, glaucoma, intraocular pressure >23 mmHg or diagnosis of ocularhypertension, cup-to-disc ratio of >0.7, or history of any glaucoma eye surgery ineither eye
Have any active ocular or peri-ocular infection; any history of recurrent or chronicinfection or inflammation in either eye
Have a history of allergic reaction to the investigational drug or any of itscomponents
Within 7 days of Screening (Visit 1), or anticipated use during the study, use ofany systemic, intranasal, topical dermatologic, or ophthalmic α-adrenergic agonist (including brimonidine) or antagonist including nasal or ocular or oraldecongestants including pseudoephedrine, oxymetazoline topical ophthalmic solution,oxymetazoline topical dermatologic cream
Subjects who are pregnant or breast-feeding
Study Design
Study Description
Connect with a study center
Eye Research Foundation
Newport Beach, California 92663
United StatesSite Not Available
Steve Yoelin Medical Associates
Newport Beach, California 92663
United StatesSite Not Available
Brian Biesman, M.D
Nashville, Tennessee 37203
United StatesSite Not Available
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