Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Inclusion Criteria:

• Presence of ptosis for at least one eye which occludes the visual axis in theresting position (without frontalis drive, lifting with forehead muscles)

• Moderate cognitive function or better defined as greater than or equal to 18 out of 30 on a pre-screening of the Mini-Mental State Exam (MMSE)

Exclusion Criteria:

• Absence of ptosis which occludes the visual axis

• Presence of a corneal ulcer of any size

• Age less than 5 years

• Severe Cognitive impairment defined as MMSE score less than 18, behaviors consistentwith delirium (combinations of disorientation, hallucinations, delusions, andincoherent speech), or lethargy.

• Presence of corneal hypoaesthesia;

• Orbicularis weakness on the side of the ptosis

• Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricialprocesses affecting the movements of the upper lid, and enophthalmos.

• Previous ptosis surgery less than 3 months prior to Visit 1.

• Lid position affected by lid or conjunctival scarring.

• History of herpes keratitis.

• Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections on the sideof the ptosis within 3 months prior to Visit 1 and during the study.

• History of hyperthyroidism or thyroid eye disease (ie, exophthalmos, upper eyelidretraction, diplopia secondary to extraocular muscle involvement). Hypothyroidismthat is controlled on medication is allowed