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NCT Number: NCT07390578

Upneeq vs. Lumify Ptosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxymetazoline 0.1% (Upneeq)

Drug

Single instillation of oxymetazoline 0.1% ophthalmic solution in both eyes.

Brimonidine 0.025% (Lumify)

Drug

Single instillation of brimonidine 0.025% ophthalmic solution in both eyes.

Primary outcomes

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

    Time frame: 60 minutes after instillation

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

Secondary outcomes

  1. Change in palpebral fissure height (PFH)

    Time frame: 60 minutes after instillation

  2. Number of participants with Conjunctival redness

    Time frame: 60 minutes after each medication

  3. Participant-reported improvement in eyelid elevation or visual function

    Time frame: 60 minutes after each medication

    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.

  4. Frequency of Adverse Events

    Time frame: 60 minutes after each medication

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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