Oxymetazoline Drops for Drooping Eyelid

Overseen By Andrew Simpson

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Milton S. Hershey Medical Center

Must not be taking: Cardiac glycosides, MAO inhibitors

Disqualifiers: Under 18, Glaucoma, Lagophthalmos, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

48 Participants Needed

Trial Summary

What is the purpose of this trial?

After an episode of facial paralysis, as nerves recover, they aberrantly regenerate and send additional branches to the incorrect muscles in addition to the intended muscle. This leads to what is known as Aberrant Regeneration Syndrome, Post-paralysis Synkinesis, or Nonflaccid Facial Paralysis. It is characterized by poor facial symmetry and function, hypertonic facial muscles at rest, and abnormal facial movements. One sequela is acquired blepharoptosis causing a smaller ocular aperture, visual field obstruction, cosmetic deformity, and abnormal periocular spasms. This study aims to evaluate an FDA approved medication for acquired blepharoptosis due to synkinesis/hyperkinesis as an adjunct to 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.

What data supports the effectiveness of the drug oxymetazoline 0.1% for treating drooping eyelid?

Research shows that oxymetazoline 0.1% can quickly lift drooping eyelids and improve vision in adults with acquired blepharoptosis (a condition where the upper eyelid droops over the eye). It has been proven effective in improving eyelid position and visual field over a period of 42 days. ^{1 2 3 4 5}

Is oxymetazoline 0.1% safe for use in humans?

Oxymetazoline 0.1% has been studied in several clinical trials for treating drooping eyelids, and it is generally considered safe for use in humans when used as directed. These studies involved using the solution once daily for periods ranging from 14 to 84 days, and no major safety concerns were reported. ^{1 2 3 4 5}

How is the drug oxymetazoline 0.1% different from other treatments for drooping eyelid?

Oxymetazoline 0.1% is unique because it is an eye drop that lifts the upper eyelid quickly and is used once daily, offering a non-surgical option for treating drooping eyelids. Unlike other treatments, it provides rapid and sustained improvement in eyelid position, enhancing vision without the need for invasive procedures. ^{1 2 3 4 5}

Research Team

Jessyka Lighthall, MD

Principal Investigator

Penn State Health

Eligibility Criteria

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

I have facial paralysis that is not completely limp and also suffer from droopy eyelids.

I am over 18 years old.

I have facial paralysis that is not completely limp and also have drooping eyelids.

Exclusion Criteria

I have difficulty fully opening one of my eyes due to weakness.

I am under 18 years old.

I am currently taking MAO inhibitors.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oxymetazoline 0.1% ophthalmic drops or preservative-free lubricating drops once daily in the affected eye

6 months

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

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.

Participant Groups

Group I: Oxymetazoline 0.1% ophthalmic drops Experimental Treatment 1 Intervention

Patients will use once daily in affected eye. Drops are provided in single use vials.

Group II: Preservative free lubricating drops Placebo Group 1 Intervention

Patients will use once daily in affected eye. Drops are provided in single use vials.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Rapid and Sustained Eyelid Elevation in Acquired Blepharoptosis with Oxymetazoline 0.1%: Randomized Phase 3 Trial Results. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Changes to Eye Whiteness and Eyelid/Brow Position With Topical Oxymetazoline in Aesthetic Patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A double-blind, multi-centre controlled trial of 0.25% oxymetazoline ophthalmic solution in patients with allergic and non-infectious conjunctivitis. [2013]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Safety of Once-Daily Oxymetazoline HCl Ophthalmic Solution, 0.1% in Patients with Acquired Blepharoptosis: Results from Four Randomized, Double-Masked Clinical Trials. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Oxymetazoline hydrochloride ophthalmic solution, 0.1%, boosts the effects of botulinum toxin on blepharospasm: a case series. [2022]