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

Sponsor

University of Miami (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04831047

Collaborator

(none)

114

Enrollment

Location

Arms

21.7

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

114 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 :

Jun 8, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in palpebral fissure height [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

Change in eye redness [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.
Patient-reported eye appearance [Day 1]
Patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey, which includes scales assessing eye appearance and upper eyelid apperarance, each with a sum score of 7 (worst) to 28 (best). Additionally, patients will be queried regarding their perception of the drop effects including changes in eye appearance after drop instillation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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