Oxymetazoline Drops for Drooping Eyelid
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests oxymetazoline eye drops to assist individuals with drooping eyelids due to facial paralysis. Nerves sometimes regrow incorrectly after paralysis, leading to poor facial symmetry and abnormal movements. The trial aims to determine if these drops can enhance eyelid appearance and function. Participants should have facial paralysis with drooping eyelids, known as acquired blepharoptosis. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking cardiac glycosides or MAO inhibitors.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that oxymetazoline 0.1% eye drops are safe and effective for treating acquired blepharoptosis, a condition where the upper eyelid droops. Studies have found that using these drops once daily for 14 to 84 days did not cause serious side effects. The treatment is considered safe for most individuals. The FDA has approved the drops, indicating they have undergone thorough testing to ensure safety and efficacy.12345
Why do researchers think this study treatment might be promising for drooping eyelid?
Most treatments for drooping eyelids, like surgery or temporary adhesive strips, are invasive or cumbersome. Unlike these options, oxymetazoline 0.1% ophthalmic drops offer a non-invasive solution. This treatment works by stimulating the muscles in the eyelid to lift naturally, providing a simpler and more convenient option. Researchers are particularly excited about the ease of use, as patients only need to apply a single drop daily. This approach not only avoids surgery but also provides a quick and easy way to potentially improve eyelid appearance and function.
What evidence suggests that oxymetazoline drops might be an effective treatment for acquired blepharoptosis?
Research shows that oxymetazoline 0.1% eye drops, which participants in this trial may receive, effectively treat acquired blepharoptosis, a condition where the upper eyelid droops. Studies have demonstrated that this treatment lifts the eyelid and improves the upper field of vision shortly after use, with effects lasting several hours. A review of multiple studies found that the drops are both effective and well-tolerated in the short term. Furthermore, it is the only FDA-approved eye drop specifically for treating ptosis, the medical term for drooping eyelids. These drops work quickly, showing significant improvement in eyelid position within minutes.56789
Who Is on the Research Team?
Jessyka Lighthall, MD
Principal Investigator
Penn State Health
Are You a Good Fit for This Trial?
This trial is for adults over 18 with nonflaccid facial paralysis and acquired blepharoptosis, a condition causing droopy eyelids due to nerve damage. It's not for those under 18, on heart medications or MAO inhibitors, with certain eye conditions like angle closure glaucoma, or uneven eye opening from weakness.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either oxymetazoline 0.1% ophthalmic drops or preservative-free lubricating drops once daily in the affected eye
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oxymetazoline 0.1% (Pf) Oph Soln Ud
- Preservative free lubricating drops
Trial Overview
The study tests Oxymetazoline drops against preservative-free lubricating drops in treating droopy eyelids caused by synkinesis after facial paralysis. The goal is to see if the FDA-approved medication can improve visual field obstruction and cosmetic appearance.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients will use once daily in affected eye. Drops are provided in single use vials.
Patients will use once daily in affected eye. Drops are provided in single use vials.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
Citations
The Use of Oxymetazoline 0.1% Ophthalmic Solution for ...
Oxymetazoline hydrochloride has been shown to be effective in some studies for acquired blepharoptosis and for aesthetic upper eyelid elevation.
Association of Oxymetazoline Hydrochloride, 0.1%, ...
Treatment with oxymetazoline, 0.1%, was associated with improved superior visual field and upper eyelid elevation vs vehicle after instillation at 1 and 14 ...
3.
dovepress.com
dovepress.com/efficacy-of-oxymetazoline-01-in-acquired-blepharoptosis-a-systematic-r-peer-reviewed-fulltext-article-OPTHEfficacy of Oxymetazoline 0.1% in Acquired Blepharoptosis
In conclusion, this meta-analysis suggests that oxymetazoline 0.1% ophthalmic solution may be an effective and well-tolerated short-term ...
Oxymetazoline Drops for Acquired Blepharoptosis From ...
Currently, it is used as a nasal decongestant, in the treatment of epistaxis, and as a topical treatment for rosacea. Previously, an ophthalmic formulation was ...
5.
reviewofoptometry.com
reviewofoptometry.com/article/aao-report-concludes-oxymetazoline-effectively-treats-ptosis-shorttermAAO Report Concludes Oxymetazoline Effectively Treats ...
the only FDA-approved drop for treating ptosis—which significantly improved eyelid elevation in just minutes as well as through six hours after ...
Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution ...
Once-daily oxymetazoline 0.1% was safe and well tolerated in participants with acquired blepharoptosis when used for 14–84 days.
7.
mayoclinic.org
mayoclinic.org/drugs-supplements/oxymetazoline-ophthalmic-route/description/drg-20065237Oxymetazoline (ophthalmic route) - Side effects & dosage
Oxymetazoline is used to treat acquired blepharoptosis, a condition wherein there is drooping or abnormal lowering of the upper eyelid.
Upneeq® | FDA-Approved Eye Drops for Low-Lying Eyelids
Upneeq is the first and only FDA-approved prescription eye drop for acquired blepharoptosis (low-lying eyelids). Proven results from one daily drop.
212520Orig1s000 - accessdata.fda.gov
Treatment with oxymetazoline hydrochloride ophthalmic solution is considered safe with a favorable adverse event profile. The adverse events ...
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