Upneeq vs. Lumify Ptosis

Comparative Effect of Oxymetazoline 0.1% (Upneeq) and Brimonidine 0.025% (Lumify) on Upper Eyelid Position in Acquired Ptosis: A Randomized, Double-Masked, Crossover Study

This study aims to compare the short-term effect of oxymetazoline 0.1% (Upneeq) versus brimonidine 0.025% (Lumify) on upper-eyelid position in adults with acquired ptosis. Participants will undergo standardized eyelid photography, receive a single dose of either Upneeq or Lumify in randomized order, and have repeat photographs approximately 60 minutes later. They will return for a second visit to receive the alternate medication using the same procedures. Eyelid height measurements will be obtained from coded images by masked graders. Data will be analyzed using paired statistical methods appropriate for a crossover design. Both medications are FDA-approved topical ophthalmic drops, and the study involves minimal risk with anticipated transient ocular irritation as the most common adverse event.

Study Overview

• Status: Not yet recruiting
• Conditions: Acquired Ptosis
• Intervention / Treatment: Drug: Oxymetazoline 0.1% (Upneeq); Drug: Brimonidine 0.025% (Lumify)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults age ≥18 years
• Acquired ptosis with MRD1 ≤ 2.5 mm in at least one eye
• Ability to complete both study visits (≥48 hours apart)
• Fluent in English
• Able to provide informed consent

Exclusion Criteria:

• Congenital ptosis or mechanical ptosis due to mass effect
• Ocular surgery within the past 6 months
• Significant active ocular surface disease
• Current contact lens wear on study days
• Known allergy to oxymetazoline or brimonidine
• Use of MAO inhibitors, α-blockers, or contraindicated medications
• Pregnancy or lactation
• Significant uncontrolled cardiovascular disease
• Any condition that may interfere with study procedures or data reliability

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upneeq First, then Lumify; Participants receive oxymetazoline 0.1% (Upneeq) at Visit 1 and brimonidine 0.025% (Lumify) at Visit 2.	Drug: Oxymetazoline 0.1% (Upneeq); Single instillation of oxymetazoline 0.1% ophthalmic solution in both eyes.; Drug: Brimonidine 0.025% (Lumify); Single instillation of brimonidine 0.025% ophthalmic solution in both eyes.
Experimental: Lumify First, then Upneeq; Participants receive brimonidine 0.025% (Lumify) at Visit 1 and oxymetazoline 0.1% (Upneeq) at Visit 2.	Drug: Oxymetazoline 0.1% (Upneeq); Single instillation of oxymetazoline 0.1% ophthalmic solution in both eyes.; Drug: Brimonidine 0.025% (Lumify); Single instillation of brimonidine 0.025% ophthalmic solution in both eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper-eyelid height (MRD1) (Upneeq vs. Lumify)	Change in MRD1 at ~60 minutes after drop instillation (Upneeq vs. Lumify)	60 minutes after instillation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in palpebral fissure height (PFH)		60 minutes after instillation
Number of participants with Conjunctival redness		60 minutes after each medication
Participant-reported improvement in eyelid elevation or visual function	Participants will report eyelid elevation and visual function on a 0-10 numeric rating scale after each medication, where: 0 = no noticeable eyelid lift and 10 = maximal eyelid lift. For visual function: 0 = no improvement in vision and 10 = maximal improvement in vision.	60 minutes after each medication
Frequency of Adverse Events	Assess the safety and tolerability of a single dose of Upneeq and Lumify.	60 minutes after each medication

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Christopher Dermarkarian, Duke University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Brimonidine; Ptosis; Oxymetazoline
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharoptosis; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Imidazoles; Quinoxalines; Brimonidine Tartrate; Oxymetazoline
• Other Study ID Numbers: Pro00119513

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.: No