Upneeq vs. Lumify Ptosis

Phase 4Not Yet RecruitingNCT07390578

Duke University50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acquired Ptosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in upper-eyelid height (MRD1) (Upneeq vs. Lumify)

Change in MRD1 at \~60 minutes after drop instillation (Upneeq vs. Lumify)

Time frame: 60 minutes after instillation

Secondary Outcomes

Change in palpebral fissure height (PFH)

Time frame: 60 minutes after instillation

Number of participants with Conjunctival redness

Time frame: 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.

Time frame: 60 minutes after each medication

Frequency of Adverse Events

Assess the safety and tolerability of a single dose of Upneeq and Lumify.

Time frame: 60 minutes after each medication