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OpenTrials
Completed

NCT Number: NCT04831047

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

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Key information

Conditions

Ptosis, Eyelid Blepharoptosis Conjunctiva Inflamed Conjunctival Diseases Conjunctivitis Eye Diseases Eye Manifestations Eyelid Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Upneeq

Placebo

Drug

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

Other names: Balanced saline solution

Primary outcomes

  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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 5, 2021
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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