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Tests treatment safety and results for Acquired Blepharophimosis
Official title 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.
ClinicalTrials.gov ID: NCT06514612
What this study is testing
What is STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers?
STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers is an investigational medicine, given as an once-daily, being studied as a potential treatment for acquired blepharophimosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Able to understand and sign an informed consent form prior to participation in any studyrelated procedures.
- Male or female people ≥ 18 years and ≤ 75 years.
- Presence of all the following at Screening:
- diagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye
- Snellen VA of 20/80 or better in both eyes Note: MRD1 is defined as the distance between upper eye lid margin and centre of the pupil. MRD0 is...
You likely can't join if
- In either eye:
- Congenital ptosis.
- Presence of either of the following:
- Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or
- Dermatochalasis that extends less than 3 mm above the upper eyelid margin.
- Neurogenic ptosis (e.g., Horner's syndrome, 3rd cranial nerve palsy).
See the full eligibility criteria
- Able to understand and sign an informed consent form prior to participation in any studyrelated procedures.
- Male or female people ≥ 18 years and ≤ 75 years.
- Presence of all the following at Screening:
- diagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye
- Snellen VA of 20/80 or better in both eyes Note: MRD1 is defined as the distance between upper eye lid margin and centre of the pupil. MRD0 is defined as the upper eye lid margin at the centre of the pupil. Measurement...
- Females who are 1-year postmenopausal, surgically sterilised, or females of childbearing potential with a negative urine pregnancy test at screening (Visit 1). Females of childbearing potential must use an acceptable...
- A male subject with a female partner of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF...
- Able to self-administer study treatment or to have the study treatment administered by a caregiver throughout the study period.
- An answer of 'Yes' to the question 'Does the ptosis cause enough burden to the subject to want to receive treatment for it'.
- Loss of ≥ 8 points not seen at or above 10° from fixation in the superior visual field of a reliable HVF 36-point ptosis protocol test at screening visit in the same eye with MRD1 ≥0 and ≤ 2 mm. If both eyes have MRD1...
- In either eye:
- Congenital ptosis.
- Presence of either of the following:
- Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or
- Dermatochalasis that extends less than 3 mm above the upper eyelid margin.
- Neurogenic ptosis (e.g., Horner's syndrome, 3rd cranial nerve palsy).
- Myogenic ptosis.
- Marcus Gunn jaw-winking syndrome.
- Previous ptosis surgery (previous blepharoplasty is allowed provided the surgery took place at least 3 months prior to screening [Visit 1]).
- Lid position affected by lid or conjunctival scarring.
- Visual field loss from any cause other than ptosis.
- History of herpes keratitis.
- Poor fixation or abnormal eye position which prevents from taking reliable pictures for MRD1 measurement.
- History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed at least 3 months prior to screening (Visit 1).
- Facial including periocular neurotoxin (e.g., Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to screening (Visit 1) and during the study.
- Topical application of bimatoprost (i.e., Latisse®) to the eyelashes within 8 days prior to screening (Visit 1) and during the study.
- Mechanical ptosis e.g., ptosis due to orbital, corneal or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
- Use of topical ophthalmic medications including anti-allergy [e.g., antihistamines], dry eye medications [e.g., IKERVIS®] (except artificial tears with anticipated stable usage during the study), antimicrobial drugs...
- Any intravitreal injections (e.g., antiVEGFs, steroids) within 8 days prior to screening (Visit 1) and during the study.
- Current punctal plugs or placement of punctal plugs during the study.
- Current use of OTC vasoconstrictor/decongestant eye medication (e.g., Visine® L.R.®) or any ophthalmic or non-ophthalmic α-adrenergic agonist including OTC products (e.g., Afrin®) at any time during the study...
- Monoamine oxidase inhibitors (MAOI) (e.g., selegiline hydrochloride, rasagiline mesilate, safinamide mesilate).
The study team makes the final eligibility decision.
Where it's taking place
- Pardubice, Czechia
- Pilsen, Czechia
- Prague, Czechia
- Bordeaux, France
- Guillon, France
- Paris, France
- Saint-Etienne, France
- Goettigen, Germany
- Göttingen, Germany
- Budapest, Hungary
- Debrecen, Hungary
- Pécs, Hungary
- Ferrara, Italy
- Naples, Italy
- Roma, Italy
- Leiden, Netherlands
- Rotterdam, Netherlands
- Gdansk, Poland
- Katowice, Poland
- Warsaw, Poland
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pardubice, Czechia; Pilsen, Czechia; Prague, Czechia; Bordeaux, France; Guillon, France; Paris, France and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.