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

Ptosis, Eyelid Clinical Trial

Official title:

The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831047
• Other study ID #: 20210199
• Status: Completed
• Phase: Phase 4
• Start date: June 8, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: April 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blepharoptosis
• Conjunctiva Inflamed
• Conjunctivitis
• Eye Manifestations
• Ptosis, Eyelid

Intervention

Drug:
• Oxymetazoline hydrochloride 0.1% ophthalmic solution
One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.
• Placebo
One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.

Locations

Country	Name	City	State
United States	University of Miami Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale	Scoring of ocular redness from clinical photographs will be performed by investigators on a 10 - 100 unit scale as compared to standardized reference photographs per the Validated Bulbar Redness grading scale (10 = minimal redness, 100 = very red) before and after drop instillation. Higher score indicates more redness.	Baseline, Day 1
Secondary	Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance	Change in patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall eye appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with eye appearance.	Baseline, Day 1
Secondary	Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance	Change in patient-reported upper eyelid appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall upper eyelid appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with upper eyelid appearance.	Baseline, Day 1