Eyelid DroopPhase 4NCT03782701
The Effect of Lumify™ Eyedrops on Eyelid Position
A Phase 4 study testing Brimonidine tartrate ophthalmic solution 0.025% and Sterile balanced saline solution in people with Eyelid Droop, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the research is to see if Lumify™ has an effect on eyelid position. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eyelid Droop
- What is being tested?
- Brimonidine tartrate ophthalmic solution 0.025% and Sterile balanced saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2019to 1 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18 and above able to provide informed consent to participate
- Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention
Who cannot join
- Adults unable to consent
- Prisoners
- Pregnant women.
- Known contradictions or sensitivities to study medication (brimonidine)
- Ocular surgery within the past 3 months or refractive surgery within the past six months
- Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
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- Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
- Significant pre-existing ptosis of any cause (defined as margin reflex distance 1 < 1mm)
- Any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters
- Presence of an active ocular infection
- Prior (within 5 days of beginning study treatment) use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines (including over the counter and herbal topical ophthalmic medications), phenylephrine dilating drops, any other topical ophthalmic agents
- Inability to sit comfortably for 15 - 30 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height
The purpose of the research is to see if Lumify™ has an effect on eyelid position.
- Conditions
- Eyelid Droop
- Being tested
- Brimonidine tartrate ophthalmic solution 0.025%, Sterile balanced saline solution
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brimonidine tartrate ophthalmic solution 0.025%Drug
Also called Lumify
One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
Sterile balanced saline solutionOther
One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
| Study group | Role | What they receive |
|---|---|---|
| Lumify Eye Drop | Active comparator | Participants will be randomized to receive a single drop of Lumify to either the left or right eye. Receives: Drug: Brimonidine tartrate ophthalmic solution 0.025% |
| Saline Solution Eye Drop | Active comparator | Participants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye. Receives: Other: Sterile balanced saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palpebral Fissure Height
Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
Measured: Baseline, 5, 15 and 30 minutes after application
Secondary outcomes (3)
Intraocular Pressure
Measurement of intraocular pressure using handheld Tono-Pen(tm) tonometer
Measured: Baseline, 5, 15 and 30 minutes after application
Eye Redness
Eye redness will be reported as the number of participants achieving a score of ocular redness from clinical photographs as 0 (none), 1 (mild), 2 (moderate) and 3 (severe).
Measured: Baseline, 5, 15 and 30 minutes after application
Eye Discomfort
Eye discomfort will be reported as the number of participants reporting subjective ocular discomfort score from 0 (none), 1 (mild), 2 (mild) and 3 (severe).
Measured: Baseline, 5, 15 and 30 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start18 Jun 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eyelid DroopStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Parallel groups
- Model description
- The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Lee, University of Miami
- Investigators
- Wendy W Lee, MD, MS, Principal investigator, Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782701
- Sponsor's protocol ID
- 20180895
- Status last verified
- Jun 2021
- First submitted
- 12 Nov 2018
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Palpebral Fissure Height
- ClinicalTrials.gov ID
- NCT03782701
- Acronym / sponsor ID
- 20180895
- Conditions
- Eyelid Droop
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to see if Lumify™ has an effect on eyelid position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The left and right eye of each subject will be randomized to receive either Lumify or balanced saline placebo.
| Arm | Type | Receives |
|---|---|---|
| Lumify Eye Drop | Active comparator | Drug: Brimonidine tartrate ophthalmic solution 0.025%Participants will be randomized to receive a single drop of Lumify to either the left or right eye. |
| Saline Solution Eye Drop | Active comparator | Other: Sterile balanced saline solutionParticipants will be randomized to receive a single drop of sterile balanced saline solution to either the left or right eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults age 18 and above able to provide informed consent to participate
- Subject with stable ocular health, defined as no ocular conditions requiring ongoing topical therapy or recent surgical intervention
Key exclusion criteria (12 listed)
- Adults unable to consent
- Prisoners
- Pregnant women.
- Known contradictions or sensitivities to study medication (brimonidine)
- Ocular surgery within the past 3 months or refractive surgery within the past six months
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 |
|---|---|---|
| Brimonidine tartrate ophthalmic solution 0.025%Also: LumifyOne time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface) | Drug | Lumify Eye Drop |
| Sterile balanced saline solutionOne time dosing of sterile balanced saline solution (1 drop applied to ocular surface) | Other | Saline Solution Eye Drop |
Primary outcome
Palpebral Fissure Height
Time frame: Baseline, 5, 15 and 30 minutes after application
Objective measurement of distance between inner margin of upper and lower eyelids from clinical photographs.
3 secondary outcomes
Intraocular Pressure
Time frame: Baseline, 5, 15 and 30 minutes after application
Eye Redness
Time frame: Baseline, 5, 15 and 30 minutes after application
Eye Discomfort
Time frame: Baseline, 5, 15 and 30 minutes after application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Wendy W Lee, MD, MS principal investigator
Bascom Palmer Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brimonidine tartrate ophthalmic solution 0.025% and Sterile balanced saline solution in people with Eyelid Droop, run by University of Miami at 1 site in United States.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Palpebral Fissure Height (time frame: Baseline, 5, 15 and 30 minutes after application). 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 14 Jun 2021.