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

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ClinicalTrials.gov Identifier: NCT04831047
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Wendy Lee, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ptosis, Eyelid Conjunctiva Inflamed Eye Manifestations Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance
Actual Study Start Date : June 8, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Balanced saline solution


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in eye redness [ Time Frame: Baseline, Day 1 ]
    Scoring of ocular redness from clinical photographs will be performed by investigators on a 0 - 4 unit scale as compared to standardized reference photographs (0 = no redness, 4 = very red) before and after drop instillation.

  2. Patient-reported eye appearance [ Time Frame: Day 1 ]
    Patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey. FACE-Q includes 4 scales, each with a sum score of 7 (worst) to 28 (best) which is converted to a scale summed score from 0 (worst) to 100 (best). These scale scores will be assessed individually and averaged to determine the total Eye Module Survey score from 0 (worst) to 100 (best).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04831047


Contacts
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Contact: Wendy W. Lee, MD 305-326-6434 wlee@med.miami.edu

Locations
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United States, Florida
University of Miami Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Marissa Shoji, MD    617-981-1134    mshojimd@gmail.com   
Principal Investigator: Wendy W Lee, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Wendy W. Lee, MD University of Miami Bascom Palmer Eye Institute
More Information
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Responsible Party: Wendy Lee, Associate Professor of Ophthalmology and Dermatology, University of Miami
ClinicalTrials.gov Identifier: NCT04831047    
Other Study ID Numbers: 20210199
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Blepharoptosis
Eye Manifestations
Conjunctivitis
Eyelid Diseases
Eye Diseases
Conjunctival Diseases
Phenylephrine
Oxymetazoline
Pharmaceutical Solutions
Ophthalmic Solutions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents