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

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What is this study about?

This clinical trial is focused on studying the treatment of acquired blepharoptosis, a condition where the upper eyelid droops over the eye, potentially affecting vision. The treatment being tested is an eye drop solution called STN1013800, which contains the active ingredient oxymetazoline hydrochloride. This medication is designed to be used twice daily to help lift the eyelid and improve vision.

The purpose of the study is to evaluate how effective and safe STN1013800 is in treating acquired blepharoptosis. Participants in the study will be randomly assigned to receive either the eye drops containing oxymetazoline hydrochloride or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for a period of 42 days, during which participants will use the eye drops and attend regular check-ups to monitor their progress.

Throughout the study, the main focus will be on measuring changes in the position of the eyelid and assessing any improvements in vision. The study aims to determine if the eye drops can effectively lift the eyelid and improve the quality of life for those with acquired blepharoptosis. Participants will be closely monitored for any side effects or changes in their condition to ensure the treatment is safe and beneficial.

1 joining the study

Upon joining the study, the participant will begin by understanding the purpose and procedures involved. This includes signing an informed consent form, which confirms understanding and agreement to participate in the study.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes a diagnosis of acquired blepharoptosis in both eyes, with specific measurements of the eyelid position and visual acuity tests to ensure the condition meets the study criteria.

3 treatment administration

The participant will receive the study medication, STN1013800 (oxymetazoline hydrochloride 0.1% eye drops), or a placebo. The medication is to be administered twice daily, once in the morning and once in the evening, for a duration of 14 days.

4 monitoring and follow-up

Throughout the study, the participant’s condition will be monitored. This includes regular check-ins to assess any changes in the eyelid position and overall eye health. The primary goal is to observe any improvement in the condition by Day 14.

5 final evaluation

On Day 14, a final evaluation will be conducted to measure the change in the eyelid position from the baseline. This will help determine the effectiveness of the treatment.

Who Can Join the Study?

Must be able to understand and sign a form agreeing to participate in the study before any study-related activities begin.
Must be a male or female aged between 18 and 75 years.
Must have a diagnosis of acquired ptosis (drooping of the upper eyelid) in both eyes, with a specific measurement called MRD1 between 0 and 2 mm in the study eye. MRD1 is the distance between the upper eyelid margin and the center of the pupil. Vision must be 20/80 or better in both eyes.
Females must be either 1-year postmenopausal, surgically sterilized, or if of childbearing potential, must have a negative pregnancy test and use an acceptable form of birth control during the study. Acceptable methods include devices like an intrauterine device, hormonal methods like pills or patches, barrier methods like condoms, or abstinence.
Male participants with a female partner who can have children should use a reliable birth control method, such as abstinence, condoms, or having had a vasectomy (a surgical procedure done at least 6 months before joining the study).
Must be able to apply the study treatment themselves or have someone to help them apply it throughout the study.
Must feel that the drooping eyelid is bothersome enough to want treatment for it.
Must have a specific loss of vision in the upper part of the visual field, as determined by a reliable test called the HVF 36-point ptosis protocol test. If both eyes meet the criteria, the eye with the more severe drooping will be the study eye. If both eyes are the same, the right eye will be chosen. The test must be reliable, and if not, it must be repeated during the screening visit.

Who Cannot Join the Study?

Patients who have any other eye condition that could affect the study results.
Patients who have had surgery on their eyelids in the past 6 months.
Patients who are currently using any medication that affects the eyes, unless they can stop using it during the study.
Patients who have a known allergy to any ingredient in the study medication.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a serious medical condition that could interfere with the study.
Patients who are unable to follow the study instructions or attend all study visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Universitaetsmedizin Goettingen	Goettingen	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Oftex s.r.o.	Pardubice	Czechia
Nozologen Kft.	Pecs	Hungary
The Rotterdam Eye Hospital	Rotterdam	The Netherlands
Fondation A De Rothschild	Paris	France
Fakultni Nemocnice Plzen	Plzen	Czechia
University Of Debrecen	Debrecen	Hungary
University Teaching Hospital Markusovszky	Szombathely	Hungary
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet	Budapest	Hungary
Centre Hospitalier Universitaire De Rennes	Rennes	France
University Of Pecs	Pecs	Hungary
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Fakultni Thomayerova nemocnice	Prague	Czechia
Budapest Retina Associates	Budapest	Hungary
Lwxjb Ulizvwmvnpsk Mcgwhub Cavzsxf (koxdu	Leiden	The Netherlands
Octrseit nvhpkqyhr Mxdca Bvokbnbw acsv nthfwslmn Stfhbmbucxiek kawws	Mlada Boleslav	Czechia
Briue Sdjcqwsrgl Kshjorja Kiol	Budapest	Hungary
Pbjuqahmphha Cyhaciz Mtngasvg Sql z ogys	Gdansk	Poland
Mqiq Czpvsdn Mwuriiwf Smhakujt	Szczecin	Poland
Geevdfp Oyelqhevzsxc pyzke Ewlrhu Wmecrexq	Katowice	Poland
Amyglnfmi Usn	Amsterdam	The Netherlands
Panpojvkl Itoapxyb Mbbexiax Mlscamxbbytl Sdjvv Whqnyiazmziv I Arrrhfgjlhcwa	Warsaw	Poland
Igrppbki dd Cotzwfkgaiab Hhuifpiawbq Uhhqakayfiecf da Snssm Exogzzd (oibqdtj	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.11.2024
France	Recruiting	01.11.2024
Germany	Not recruiting	01.11.2024
Hungary	Recruiting	01.11.2024
Italy	Recruiting	01.11.2024
Poland	Recruiting	01.11.2024
Spain	Recruiting	01.11.2024
The Netherlands	Recruiting	01.11.2024

Trial locations

Investigated drugs:

Oxymetazoline Hydrochloride

STN1013800: This is an eye drop medication being tested for its effectiveness and safety in treating acquired blepharoptosis, a condition where the upper eyelid droops over the eye. The medication is applied twice daily to see if it can help lift the eyelid and improve vision.

Acquired Blepharoptosis – This condition is characterized by the drooping of the upper eyelid, which can occur in one or both eyes. It is often due to the weakening or dysfunction of the muscles responsible for lifting the eyelid. Over time, the drooping can become more pronounced, potentially affecting vision if the eyelid covers the pupil. The condition can develop gradually or appear suddenly, depending on the underlying cause. It is more common in older adults but can occur at any age. The progression of the drooping can vary, with some individuals experiencing a slow change and others noticing a more rapid onset.

Trial ID:

2024-513356-15-00

Protocol code:

101380003SA

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?