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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04831047
Other study ID # 20210199
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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