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

Site Name City Country Status
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
University Of Debrecen Debrecen Hungary
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universidade De Santiago De Compostela Santiago De Compostela Spain
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Centre Hospitalier Universitaire De Rennes Rennes France
Universita’ Degli Studi Di Ferrara Ferrara Italy
Hospital Universitario Virgen De Las Nieves Granada Spain
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Fondation A De Rothschild Paris France
Fakultni Nemocnice Plzen Plzen Czechia
University Teaching Hospital Markusovszky Szombathely Hungary
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD Varna Bulgaria
Fakultni Thomayerova nemocnice Prague Czechia
Budapest Retina Associates Budapest Hungary
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet Budapest Hungary
University Of Pecs Pecs Hungary
The Rotterdam Eye Hospital Rotterdam The Netherlands
Nozologen Kft. Pecs Hungary
Oftex s.r.o. Pardubice Czechia
Gabinet Okulistyczny Prof. Edward Wylegala Katowice Poland
Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases – Dr. Grupchevi Varna Bulgaria
Clinica Vista Vision Bucuresti Bucharest Romania
Ayxvluzbm Ujg Amsterdam The Netherlands
Ofhufepj nizbrgfnv Mkfuc Bpfclftj afel nkdhoteug Sjxhqsuihdwap kspvm Mlada Boleslav Czechia
Ieriudal dx Cjfmoqqzczwl Hbniqqqdzss Ulrmociepranf dr Sdrzp Ekicvcq (sfjtbaa Saint Priest En Jarez France
Mpck Copgcvh Mstxbihd Szsmzwfp Szczecin Poland
Bhclu Sixthaiybv Kkyqchmg Kbbg Budapest Hungary
Pkguwvftn Iafjfpws Moxcxjhq Motellkkhnec Sdipf Wxexzshicpbi I Avqvunyvjsqzi Warsaw Poland
Lwxsa Uqcxylpbexlj Momtrgg Cgbxwhl (owiyn Leiden The Netherlands
Pajuhytyvqyo Cljvjeb Myvzaoot Sbp z oerf Gdansk Poland
Demsefqxkk Ccnwowtxvexg Cmqlxy Evvfgb Olc Varna Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

Trial locations

Investigated Drugs:

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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