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

NCT04831047 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20210199
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ptosis, Eyelid; Conjunctiva Inflamed; Eye Manifestations

Outcome Measures

Primary Outcomes (1)

• Change in Palpebral Fissure Height

  Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation.

  Baseline, Day 1

Secondary Outcomes (3)

• Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale

  Baseline, Day 1

• Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance

  Baseline, Day 1

• Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance

  Baseline, Day 1

Study Arms (2)

Upneeq Group

EXPERIMENTAL

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)

Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution

Control Group

SHAM COMPARATOR

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)

Drug: Placebo

Interventions

Oxymetazoline hydrochloride 0.1% ophthalmic solution DRUG

One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.

Also known as: Upneeq

Upneeq Group

Placebo DRUG

One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.

Also known as: Balanced saline solution

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Shoji MK, Markatia Z, Ameli K, Bayaraa M, Clauss KD, Ugradar S, Lee WW. The effects of topical oxymetazoline on eyelid position, eye redness, and patient-reported eye appearance: A randomized controlled trial. J Plast Reconstr Aesthet Surg. 2023 May;80:66-74. doi: 10.1016/j.bjps.2023.02.006. Epub 2023 Feb 9.

  PMID: 36996503 DERIVED

MeSH Terms

Conditions

Blepharoptosis; Conjunctivitis; Eye Manifestations

Interventions

Oxymetazoline; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Conjunctival Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Wendy W. Lee MD
• Organization: Bascom Palmer Eye Institute

wlee@med.miami.edu

305-243-6434

Study Officials

• Wendy W. Lee, MD

  University of Miami Bascom Palmer Eye Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology and Dermatology

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: June 8, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 24, 2023
• Results First Posted: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)