Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

January 11, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

July 31, 2026

Conditions
BlepharoptosisSynkinesisHyperkinesisFacial Paralysis
Interventions
DRUG

Oxymetazoline 0.1% (Pf) Oph Soln Ud

"Oxymetazoline was initially developed in 1961. It is a direct sympathomimetic, binding directly to alpha-1 and alpha-2 receptors. Currently, it is used as a nasal decongestant, in the treatment of epistaxis, and as a topical treatment for rosacea. Previously, an ophthalmic formulation was used to treat eye redness and irritation as it is FDA approved for the treatment of acquired blepharoptosis. However, this product line was discontinued when in July of 2020, oxymetazoline received Food and Drug Administration approval for treatment of cosmetic blepharoptosis.~In the treatment of blepharoptosis, oxymetazoline acts on the superior tarsal muscle, Müller's muscle, to elevate the eyelid. The superior tarsal muscle is a sympathetically innervated muscle that is partially responsible for elevating the eyelid. Previous cosmetic studies have shown oxymetazoline can serve as an adjunct to botulinum toxin in patients with acquired blepharoptosis."

OTHER

Preservative free lubricating drops

Over the counter ophthalmic lubricating drop.

Trial Locations (1)

17033

M.S. Hershey Medical Center, Hershey

All Listed Sponsors
lead

Milton S. Hershey Medical Center

OTHER