The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance

University of Miami

Status and phase: Completed; Phase 4

Conditions: Eye Manifestations; Ptosis, Eyelid; Conjunctiva Inflamed

Treatments: Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04831047

20210199

Details and patient eligibility

About

The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults age 18 and above able to provide informed consent to participate
• Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention

Exclusion criteria

• Adults unable to consent
• Individuals less than 18 years of age
• Prisoners
• Pregnant women.
• Known contradictions or sensitivities to study medication (oxymetazoline)
• Ocular surgery within the past 3 months or refractive surgery within the past six months
• Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
• Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
• Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
• Presence of an active ocular infection
• Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
• Inability to sit comfortably for 15 - 30 minutes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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114 participants in 2 patient groups

Upneeq Group

Experimental group

Description:

Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group)

Treatment:

Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution

Control Group

Sham Comparator group

Description:

Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group)

Treatment:

Drug: Placebo