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Oxymetazoline Drops for Drooping Eyelid

Phase 3
Waitlist Available
Led By Jessyka Lighthall, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary diagnosis of nonflaccid facial paralysis (aberrant regeneration syndrome) and acquired blepharoptosis.
Over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is exploring a medication to help treat a medical condition caused by nerve misfiring after facial paralysis. Symptoms include poor symmetry, abnormal movement, and eye droop.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of Oxymetazoline may include temporary burning or stinging in the eyes, dryness or redness of the inside lining of the eyelid, sneezing, nausea, dizziness, headache.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have facial paralysis that is not completely limp and also suffer from droopy eyelids.
Select...
I am over 18 years old.
Select...
I have facial paralysis that is not completely limp and also have drooping eyelids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference from baseline to end of study Synkinesis Assessment Questionnaire
Difference from baseline to end of study in Facial Disability Index
Difference from baseline to end of study in Sunnybrook Grading Score
Secondary outcome measures
Difference in MRD-1 from baseline to when medication is being used
Difference in palpebral height from baseline to when medication is being used

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oxymetazoline 0.1% ophthalmic dropsExperimental Treatment1 Intervention
Patients will use once daily in affected eye. Drops are provided in single use vials.
Group II: Preservative free lubricating dropsPlacebo Group1 Intervention
Patients will use once daily in affected eye. Drops are provided in single use vials.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,774 Total Patients Enrolled
Jessyka Lighthall, MDPrincipal InvestigatorPenn State Health
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

Oxymetazoline 0.1% (Pf) Oph Soln Ud (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05945615 — Phase 3
Facial Palsy Research Study Groups: Oxymetazoline 0.1% ophthalmic drops, Preservative free lubricating drops
Facial Palsy Clinical Trial 2023: Oxymetazoline 0.1% (Pf) Oph Soln Ud Highlights & Side Effects. Trial Name: NCT05945615 — Phase 3
Oxymetazoline 0.1% (Pf) Oph Soln Ud (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05945615 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you have any available slots for participants in this experimental process?

"Data hosted on clinicaltrials.gov states that this medical trial is not actively recruiting patients at present, despite being initially posted in the beginning of August 2023 and updated as recently as July 6th 2023. Nonetheless, 166 other studies are currently enrolling volunteers."

Answered by AI

Does this clinical trial include participants aged 65 and over?

"Patients aged 18 to 99 are being enrolled in this trial."

Answered by AI

How secure are the effects of Oxymetazoline 0.1% ophthalmic drops for users?

"Our experts have rated the safety of Oxymetazoline 0.1% ophthalmic drops as a 3, indicating that there is clinical evidence backing its efficacy and multiple studies verifying its security."

Answered by AI

Who is eligible to join this investigation?

"To qualify for this research, potential participants must suffer from facial palsy and lie within the 18-99 year old age bracket. The team is currently seeking 48 individuals to participate in the investigation."

Answered by AI

Who else is applying?

What site did they apply to?
M.S. Hershey Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I’ve had ptosis surgery and didn’t work in one eye.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis
Jessyka Lighthall 2024. "Oxymetazoline Drops for Acquired Blepharoptosis From Synkinesis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05945615.
All > Bells Palsy
~30 spots leftby Oct 2024
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