Acquired Ptosis
Conditions
Keywords
Ptosis, Oxymetazoline, Brimonidine
Brief summary
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
DRUGOxymetazoline 0.1% (Upneeq)
Single instillation of oxymetazoline 0.1% ophthalmic solution in both eyes.
DRUGBrimonidine 0.025% (Lumify)
Single instillation of brimonidine 0.025% ophthalmic solution in both eyes.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in upper-eyelid height (MRD1) (Upneeq vs. Lumify) | 60 minutes after instillation | Change in MRD1 at \~60 minutes after drop instillation (Upneeq vs. Lumify) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Frequency of Adverse Events | 60 minutes after each medication | Assess the safety and tolerability of a single dose of Upneeq and Lumify. |
Contacts
PRINCIPAL_INVESTIGATORChristopher Dermarkarian
Duke University
Outcome results
None listed