Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis

Exclusion Criteria

• •In either eye
• •1. Congenital ptosis.
• •2. Presence of either of the following:
• •1. Pseudoptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin) or
• •2. Dermatochalasis that extends less than 3 mm above the upper eyelid margin.
• •3. Horner syndrome.
• •4. Marcus Gunn jaw winking syndrome.
• •5. Myasthenia gravis.
• •6. Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
• •7. Previous ptosis surgery (previous blepharoplasty \[only\] is allowed provided the surgery took place \> 3 months prior to Visit 1).
• •8. Lid position affected by lid or conjunctival scarring.
• •9. Visual field loss from any cause other than ptosis.
• •10. History of herpes keratitis.
• •11. History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed \> 3 months prior to Visit 1).
• •12. Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to Visit 1 and during the study.
• •13. Topical application of bimatoprost (ie, Latisse®) to the eyelashes within 7 days prior to Visit 1 and during the study.
• •14. Use of topical ophthalmic medications (including anti-allergy \[eg, antihistamines\], dry eye \[ie, Restasis®\] and anti-inflammatory drugs \[including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids\] other than the assigned study medication within 7 days prior to Visit 1 and during the study. Topical ophthalmic prostaglandin analogues for the treatment of elevated intraocular pressure are permitted if dosed in the evening in accordance with the approved prescribing information. All other topical antiglaucoma medications are prohibited
• •15. Intravitreal injections (eg, Lucentis®, Eylea®, Avastin®, Triesence®) within 7 days prior to Visit 1 and during the study.
• •16. Current punctal plugs or placement of punctal plugs during the study.
• •17. Use of over the counter (OTC) vasoconstrictor/decongestant eye medication (eg, Visine® L.R.®) or any ophthalmic or non-ophthalmic α adrenergic agonist including OTC products (eg, Afrin®) at any time during the study; nonpreserved artificial tears are allowed.
• •General
• •18. Resting heart rate (HR) outside the normal range (60-100 beats per minute).
• •19. Hypertension with resting diastolic blood pressure (BP) \> 105 mm Hg.
• •20. Use of monoamine oxidase inhibitors (MAOIs; eg, isocarboxazid, phenelzine, tranylcypromine) within 14 days prior to Visit 1 and during the study.
• •21. Advanced arteriosclerotic disease or history of cerebrovascular accident (CVA).
• •22. 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.
• •23. Patients with diabetic retinopathy may not be enrolled. However, patients with insulin dependent diabetes, diabetes requiring oral hypoglycemic drugs, or diet controlled diabetes are allowed.
• •24. Pregnancy or lactation.
• •25. Diagnosed benign prostatic hypertrophy requiring medicinal therapy; previous prostatectomy is allowed.
• •26. History of contact or systemic allergic reaction to oxymetazoline or other sympathomimetic drugs (eg, phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, fepradinol, or methoxamine).