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

April 21, 2023 updated by: Wendy Lee, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Bascom Palmer Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upneeq Group
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
One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.
Other Names:
  • Upneeq
Sham Comparator: Control Group
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
One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.
Other Names:
  • Balanced saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Palpebral Fissure Height
Time Frame: Baseline, Day 1
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale
Time Frame: Baseline, Day 1
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
Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance
Time Frame: Baseline, Day 1
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
Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance
Time Frame: Baseline, Day 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Wendy W. Lee, MD, University of Miami Bascom Palmer Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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