Menu
Not yet recruiting NCT07390578

Upneeq vs. Lumify Ptosis

Phase IV Interventional Acquired Ptosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxymetazoline 0.1% (Upneeq), Brimonidine 0.025% (Lumify).
Who it may be relevant to
Registry conditions: Acquired Ptosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

  • 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.

Primary outcome measures

  • Change in upper-eyelid height (MRD1) (Upneeq vs. Lumify) [Time frame: 60 minutes after instillation]
Secondary outcome measures (4)
  • 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 [Time frame: 60 minutes after each medication]
  • Frequency of Adverse Events [Time frame: 60 minutes after each medication]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07390578 · Pro00119513

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗