Clinical Trial Comparing Two Non-Surgical Treatments for Severe Blepharoptosis

Prior treatment

• Previous ptosis surgery less than 3 months prior to Visit 1.
• Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections on the side of the ptosis within 3 months prior to Visit 1 and during the study.

Other illness

• Presence of a corneal ulcer of any size
• Severe Cognitive impairment defined as MMSE score less than 18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy.
• History of herpes keratitis.
• History of hyperthyroidism or thyroid eye disease (ie, exophthalmos, upper eyelid retraction, diplopia secondary to extraocular muscle involvement). Hypothyroidism that is controlled on medication is allowed

Age

• Age less than 5 years

Other

• Absence of ptosis which occludes the visual axis
• Presence of corneal hypoaesthesia;
• Orbicularis weakness on the side of the ptosis
• Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
• Lid position affected by lid or conjunctival scarring.

• Presence of ptosis for at least one eye which occludes the visual axis in the resting 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)