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RecruitingPHASE3INTERVENTIONAL

LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis.

This study, called LIDRISE, is testing new eye drops, STN1013800, for a common condition where the upper eyelids droop, called acquired blepharoptosis. The main goal is to find out if these eye drops can safely and effectively lift the eyelids and improve vision. Researchers will compare STN1013800 to a dummy medicine (placebo) to see if it works better. About 234 adults aged 18 to 75 will take part. Participants will be given either the new eye drops or the placebo to use twice a day for 6 weeks. There will be study visits to check progress and safety, with a follow-up visit after the treatment ends.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Santen SAS
Enrolment target
234
Start
30 Dec 2024
Estimated completion
01 Aug 2026

What is this study about?

This research study, called LIDRISE, is investigating a new eye drop treatment, STN1013800, for a condition called acquired blepharoptosis. This is a common situation where your upper eyelids start to droop, often as you get older. This drooping can sometimes affect your vision, making it harder to see. The study aims to find out if these new eye drops can safely and effectively help lift the eyelids of people with this condition.

To make sure the results are reliable, the study will compare the new eye drops to a "dummy" medicine, called a placebo. A placebo looks just like the real medicine but doesn't contain any active ingredients. Neither you nor your study doctor will know whether you are receiving the real eye drops or the placebo; this is called "double-masked". This helps ensure that any improvements seen are truly due to the medicine and not other factors.

This is a "Phase 3" study, which means the new eye drops have already been tested in smaller groups of people and shown some promise. This larger study is the final step before the new drops could potentially be approved for wider use. By taking part, you could contribute to developing new treatment options for people with droopy eyelids.

Key takeaways

  • This study tests new eye drops for droopy eyelids (acquired blepharoptosis).
  • It compares the new drops to a dummy medicine to check for safety and effectiveness.
  • Around 234 adults (18-75 years old) will take part for about 8-9 weeks.
  • Participants use drops twice daily for 6 weeks and attend several study visits.
  • You have the right to leave the study at any time.

Who may be eligible?

To be considered for this study, you would generally need to be an adult between 18 and 75 years old.

You must have been diagnosed with acquired blepharoptosis, which means your eyelids have started to droop, specifically in both eyes. The doctors will measure the amount of droop in your eyelid (called MRD1), and it needs to be within a specific range to qualify. It's also important that your eyesight is reasonably good (20/80 or better) in both eyes.

Beyond these medical requirements, you need to be able to understand and sign the consent form to show you agree to take part. Also, you must feel that your droopy eyelids bother you enough to want treatment for them. There are also specific rules about contraception for both men and women if they are able to have children, to ensure safety during the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 75 years old?
  2. Do you have droopy upper eyelids in both eyes?
  3. Does your droopy eyelid bother you enough to want treatment?
  4. Can you or a caregiver use eye drops twice a day?
  5. Are you able to attend several appointments over about 8-9 weeks?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have a screening visit to check if you meet all the requirements. If you do, you'll return for a second visit within 8 days. At this visit, you'll be given either the new eye drops or the dummy drops. Neither you nor the study team will know which you're receiving.

You will use the assigned eye drops twice a day for 6 weeks. There will be study visits at 2 weeks and 6 weeks to see how you're doing and to check for any side effects. On some specific visit days, you'll take your morning or afternoon dose at the clinic, and on other days you'll take it at home. Two weeks after you finish using the eye drops, you'll have one final follow-up visit. The total time you'd be involved in the study from start to finish would be around 8-9 weeks.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit could be that the new eye drops improve your droopy eyelids, which might help your vision and how you feel about your appearance. However, there's also a chance you could receive the dummy medicine and not experience any improvements. As with any medicine, there's a risk of side effects from the eye drops, even if they are minor. The study team will monitor you closely for any reactions. You will be told about all known potential risks before you decide to take part. Remember, joining this study is entirely your choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (36)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Oftex.s.r.o, oční klinika
    Verified postcode
    Pardubice, Czechia· Recruiting
  • Fakultni nemocnice Plzeň, Oční oddělení
    Verified postcode
    Pilsen, Czechia· Recruiting
  • Fakultni Thomayerova nemocnice
    Verified postcode
    Prague, Czechia· Recruiting
  • Clinique Ophtalmologique Thiers
    Verified postcode
    Bordeaux, France· Recruiting
  • CHU Rennes - PONTCHAILLOU Service ophtalmologie
    Verified postcode
    Guillon, France· Recruiting
  • Hôpital Fondation Adolphe de Rothschild
    Verified postcode
    Paris, France· Recruiting
  • CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie
    Verified postcode
    Saint-Etienne, France· Recruiting
  • Unversitaetsmedizin Goettingen
    Unverified
    Goettigen, Germany· Recruiting
  • Universitätsmedizin Göttingen; Georg-August-Universität
    Verified postcode
    Göttingen, Germany· Recruiting
  • Budapest Retina Associates
    Verified postcode
    Budapest, Hungary· Recruiting
  • Budapesti Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
    Verified postcode
    Budapest, Hungary· Recruiting
  • Észak-Pesti Centrumkórház - Honvédkórház
    Verified postcode
    Budapest, Hungary· Recruiting

Common questions

What is acquired blepharoptosis?

It's a condition where your upper eyelids start to droop, usually due to age or how your eyes work, rather than being born with it.

What does 'double-masked' mean?

It means neither you nor your study doctor will know if you're getting the new medicine or the dummy medicine. This helps keep the study fair.

How often do I use the eye drops?

You'll use the eye drops twice a day, every day, for 6 weeks.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without any consequences to your healthcare.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real treatment but contains no active ingredients. It's used for comparison in studies.

How to find out more

Santen SAS Clinical Operations

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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