Ptosis, EyelidPhase 4NCT04831047
The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
A Phase 4 study testing Oxymetazoline hydrochloride 0.1% ophthalmic solution in people with Ptosis, Eyelid and Conjunctiva Inflamed, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ptosis, Eyelid, Conjunctiva Inflamed, Eye Manifestations
- What is being tested?
- Oxymetazoline hydrochloride 0.1% ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 1 Apr 2022
- 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
- Individuals less than 18 years of age
- Prisoners
- Pregnant women.
- Known contradictions or sensitivities to study medication (oxymetazoline)
- Ocular surgery within the past 3 months or refractive surgery within the past six months
Show all 12Show fewer
- Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital surgery
- Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or blepharospasm)
- 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.
United States1 site
University of Miami Bascom Palmer Eye Institute
Miami, Florida, 33136
About this study
Official title: The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance
The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.
- Conditions
- Ptosis, Eyelid, Conjunctiva Inflamed, Eye Manifestations
- Being tested
- Oxymetazoline hydrochloride 0.1% ophthalmic solution, Placebo
- Medical subject headings
- Blepharoptosis, Conjunctivitis, Eye Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxymetazoline hydrochloride 0.1% ophthalmic solutionDrug
Also called Upneeq
One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.
PlaceboDrug
Also called Balanced saline solution
One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.
| Study group | Role | What they receive |
|---|---|---|
| Upneeq Group | Experimental | Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) Receives: Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solution |
| Control Group | Sham comparator | Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Palpebral Fissure Height
Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation.
Measured: Baseline, Day 1
Secondary outcomes (3)
Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale
Scoring of ocular redness from clinical photographs will be performed by investigators on a 10 - 100 unit scale as compared to standardized reference photographs per the Validated Bulbar Redness grading scale (10 = minimal redness, 100 = very red) before and after drop instillation. Higher score indicates more redness.
Measured: Baseline, Day 1
Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance
Change in patient-reported eye appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall eye appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with eye appearance.
Measured: Baseline, Day 1
Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance
Change in patient-reported upper eyelid appearance will be assessed by patient completion of the FACE-Q Eye Module Survey assessing overall upper eyelid appearance with a sum score of 7 (worst) to 28 (best) at baseline and after drop administration. Higher score indicates a higher level of satisfaction with upper eyelid appearance.
Measured: Baseline, Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start8 Jun 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ptosis, EyelidStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 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, Principal investigator, University of Miami Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831047
- Sponsor's protocol ID
- 20210199
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2021
- Last updated
- 24 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shoji MK, Markatia Z, Ameli K, Bayaraa M, Clauss KD, Ugradar S, Lee WW. The effects of topical oxymetazoline on eyelid position, eye redness, and patient-reported eye appearance: A randomized controlled trial. J Plast Reconstr Aesthet Surg. 2023 May;80:66-74. doi: 10.1016/j.bjps.2023.02.006. Epub 2023 Feb 9.
PubMed 36996503
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Palpebral Fissure Height, Eye Redness, and Patient-reported Eye Appearance
- ClinicalTrials.gov ID
- NCT04831047
- Acronym / sponsor ID
- 20210199
- Conditions
- Ptosis, Eyelid, Conjunctiva Inflamed, Eye Manifestations
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Posted 24 Apr 2023
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 Upneeq ( oxymetazoline 0.1% ophthalmic solution) has an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upneeq Group | Experimental | Drug: Oxymetazoline hydrochloride 0.1% ophthalmic solutionParticipants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group) |
| Control Group | Sham comparator | Drug: PlaceboParticipants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group) |
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
- Individuals less than 18 years of age
- Prisoners
- Pregnant women.
- Known contradictions or sensitivities to study medication (oxymetazoline)
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 hydrochloride 0.1% ophthalmic solutionAlso: UpneeqOne drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye. | Drug | Upneeq Group |
| PlaceboAlso: Balanced saline solutionOne drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye. | Drug | Control Group |
Primary outcome
Change in Palpebral Fissure Height
Time frame: Baseline, Day 1
Palpebral fissure height will be calculated from the sum of marginal reflex distance 1 and 2 measured from the photograph by Ipad software and recorded by investigators before and after drop instillation.
3 secondary outcomes
Change in Eye Redness as Measured by the Validated Bulbar Redness Grading Scale
Time frame: Baseline, Day 1
Change in Patient-reported Eye Appearance - FACE-Q Eye Appearance
Time frame: Baseline, Day 1
Change in Patient-reported Eye Appearance - FACE-Q Upper Eyelid Appearance
Time frame: Baseline, Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36996503Shoji MK, Markatia Z, Ameli K, Bayaraa M, Clauss KD, Ugradar S, Lee WW. The effects of topical oxymetazoline on eyelid position, eye redness, and patient-reported eye appearance: A randomized controlled trial. J Plast Reconstr Aesthet Surg. 2023 May;80:66-74. doi: 10.1016/j.bjps.2023.02.006. Epub 2023 Feb 9.
- 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 principal investigator
University of Miami 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 Oxymetazoline hydrochloride 0.1% ophthalmic solution in people with Ptosis, Eyelid and Conjunctiva Inflamed, 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 24 Apr 2023. 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. Some participants in this study may receive a placebo. 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 24 Apr 2023). 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?
Change in Palpebral Fissure Height (time frame: Baseline, Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04831047, which also lists 1 linked publication.
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 24 Apr 2023.