Phase 4
N=114
The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
Ptosis, Eyelid · Conjunctiva Inflamed · Eye Manifestations
Bottom Line
View on ClinicalTrials.gov: NCT04831047 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change in Palpebral Fissure Height — 1.1; -0.4 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxymetazoline hydrochloride 0.1% ophthalmic solution (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Palpebral Fissure Height |
1.1; -0.4 | — |
| SECONDARY Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale |
-2.6; -0.5 | — |
| SECONDARY Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance |
4.2; 0.8 | — |
| SECONDARY Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance |
0.9; -0.5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04831047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.