Acquired PtosisPhase 4NCT07390578
Upneeq vs. Lumify Ptosis
A Phase 4 study testing Oxymetazoline 0.1% (Upneeq) and Brimonidine 0.025% (Lumify) in people with Acquired Ptosis, run by Duke University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Ptosis
- What is being tested?
- Oxymetazoline 0.1% (Upneeq) and Brimonidine 0.025% (Lumify)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnancy or lactation
- Significant uncontrolled cardiovascular disease
- Any condition that may interfere with study procedures or data reliability
About this study
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
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.
- Conditions
- Acquired Ptosis
- Being tested
- Oxymetazoline 0.1% (Upneeq), Brimonidine 0.025% (Lumify)
- Keywords
- Ptosis, Oxymetazoline, Brimonidine
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Upneeq First, then Lumify | Experimental | Participants receive oxymetazoline 0.1% (Upneeq) at Visit 1 and brimonidine 0.025% (Lumify) at Visit 2. Receives: Drug: Oxymetazoline 0.1% (Upneeq); Drug: Brimonidine 0.025% (Lumify) |
| Lumify First, then Upneeq | Experimental | Participants receive brimonidine 0.025% (Lumify) at Visit 1 and oxymetazoline 0.1% (Upneeq) at Visit 2. Receives: Drug: Oxymetazoline 0.1% (Upneeq); Drug: Brimonidine 0.025% (Lumify) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper-eyelid height (MRD1) (Upneeq vs. Lumify)
Change in MRD1 at ~60 minutes after drop instillation (Upneeq vs. Lumify)
Measured: 60 minutes after instillation
Secondary outcomes (4)
Change in palpebral fissure height (PFH)
Measured: 60 minutes after instillation
Number of participants with Conjunctival redness
Measured: 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.
Measured: 60 minutes after each medication
Frequency of Adverse Events
Assess the safety and tolerability of a single dose of Upneeq and Lumify.
Measured: 60 minutes after each medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired PtosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Dermarkarian, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390578
- Sponsor's protocol ID
- Pro00119513
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07390578
- Acronym / sponsor ID
- Pro00119513
- Conditions
- Acquired Ptosis
- Keywords
- Ptosis, Oxymetazoline, Brimonidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upneeq First, then Lumify | Experimental | Drug: Oxymetazoline 0.1% (Upneeq), Drug: Brimonidine 0.025% (Lumify)Participants receive oxymetazoline 0.1% (Upneeq) at Visit 1 and brimonidine 0.025% (Lumify) at Visit 2. |
| Lumify First, then Upneeq | Experimental | Drug: Oxymetazoline 0.1% (Upneeq), Drug: Brimonidine 0.025% (Lumify)Participants receive brimonidine 0.025% (Lumify) at Visit 1 and oxymetazoline 0.1% (Upneeq) at Visit 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxymetazoline 0.1% (Upneeq)Single instillation of oxymetazoline 0.1% ophthalmic solution in both eyes. | Drug | Lumify First, then Upneeq, Upneeq First, then Lumify |
| Brimonidine 0.025% (Lumify)Single instillation of brimonidine 0.025% ophthalmic solution in both eyes. | Drug | Lumify First, then Upneeq, Upneeq First, then Lumify |
Primary outcome
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)
4 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
Time frame: 60 minutes after each medication
Frequency of Adverse Events
Time frame: 60 minutes after each medication
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Dermarkarian principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxymetazoline 0.1% (Upneeq) and Brimonidine 0.025% (Lumify) in people with Acquired Ptosis, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper-eyelid height (MRD1) (Upneeq vs. Lumify) (time frame: 60 minutes after instillation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.