Eyelid ptosis Trials in Disease

Study on the Effectiveness and Safety of Oxymetazoline Hydrochloride Eye Drops for Adults with Acquired Blepharoptosis

This clinical trial focuses on testing a treatment for acquired blepharoptosis, a condition where the upper eyelid droops over the eye and can affect vision. The drooping happens when the muscles responsible for lifting the eyelid weaken or don't work properly. While this condition is more common in older adults, it can occur at any age and may develop gradually or suddenly.

Main inclusion criteria:

• Adults aged between 18 and 75 years
• Diagnosed with acquired ptosis in both eyes, with a specific measurement called MRD1 between 0 and 2 mm in the study eye (this measures the distance between the upper eyelid margin and the center of the pupil)
• Vision of 20/80 or better in both eyes
• Must find the drooping eyelid bothersome enough to want treatment
• Must have a specific loss of vision in the upper visual field, confirmed by a reliable test
• Able to apply the eye drops themselves or have someone to help them
• Women of childbearing age must use reliable birth control methods during the study

Main exclusion criteria:

• Any other eye condition that could affect the study results
• Eyelid surgery within the past 6 months
• Currently using medications that affect the eyes (unless they can be stopped during the study)
• Known allergy to any ingredient in the study medication
• Pregnancy or breastfeeding
• Participation in another clinical trial within the last 30 days
• Serious medical conditions that could interfere with the study
• Unable to follow study instructions or attend all visits

Focus and goal of the trial:

The study aims to evaluate whether STN1013800 eye drops can effectively lift the drooping eyelid and improve vision in people with acquired blepharoptosis. Participants will be randomly assigned to receive either the active medication or a placebo (which looks like the real medication but contains no active ingredient). The study will last 42 days, with treatment applied twice daily for 14 days. The main measurement will focus on changes in eyelid position from the beginning of the study to Day 14. Throughout the trial, participants will have regular check-ups to monitor progress and check for any side effects.

Investigational drug:

The medication being tested is STN1013800, which contains oxymetazoline hydrochloride at 0.1% concentration. This medication works by stimulating alpha-adrenergic receptors, which causes muscle contraction and helps lift the eyelid. The eye drops are applied twice daily, once in the morning and once in the evening.

Summary

Currently, one clinical trial is actively recruiting participants across eight European countries to study a potential treatment for eyelid ptosis. The trial is being conducted in Poland, France, Netherlands, Hungary, Italy, Czechia, Spain, and Germany, offering broad geographic access for eligible participants.

The study focuses specifically on oxymetazoline hydrochloride eye drops as a non-surgical treatment option for acquired blepharoptosis. This approach may be particularly appealing to patients seeking alternatives to surgical intervention. The trial uses a placebo-controlled design to properly assess the medication's effectiveness and safety.

Patients interested in participating should be aware that the condition must affect both eyes with specific measurements, and vision must meet certain criteria. The relatively short treatment period of 14 days, within a total study duration of 42 days, makes this trial accessible for many potential participants.