| Eligibility |
Inclusion Criteria:
Subjects who meet all the following inclusion criteria will be eligible to participate in
the study. Subjects must:
1. Be male or female subjects 25 years of age or older at the time of Screening (Visit 1)
2. Have complaints of aesthetically unacceptable upper eyelid position for both eyes
making them desirous for elevation, or have complaints of superior visual field
defects in both eyes that impact activities of daily living
3. Present with the following at Screening (Visit 1):
a. At least one eye that meets both of the following criteria: i. Margin Reflex
Distance 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, in
the 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 change from
baseline in MRD1 in both eyes in response to a single drop of oxymetazoline 0.1%
ophthalmic solution)to each eye at Screening
4. Women of Childbearing Potential must agree to use an approved method of birth control
from the date they sign the informed consent form (ICF) until after the last study
visit (Follow-Up Visit)
5. Be able to give informed consent and willing to comply with all study visits and
examinations
Exclusion Criteria:
1. Have any other ocular pathology other than ptosis requiring treatment with topical
prescription ophthalmic drops in either eye (e.g., glaucoma, dry eye)
2. Have narrow angles, glaucoma, intraocular pressure >23 mmHg or diagnosis of ocular
hypertension, cup-to-disc ratio of >0.7, or history of any glaucoma eye surgery in
either eye
3. Have any active ocular or peri-ocular infection; any history of recurrent or chronic
infection or inflammation in either eye
4. Have a history of allergic reaction to the investigational drug or any of its
components
5. Within 7 days of Screening (Visit 1), or anticipated use during the study, use of any
systemic, intranasal, topical dermatologic, or ophthalmic a-adrenergic agonist
(including brimonidine) or antagonist including nasal or ocular or oral decongestants
including pseudoephedrine, oxymetazoline topical ophthalmic solution, oxymetazoline
topical dermatologic cream
6. Subjects who are pregnant or breast-feeding
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