Actively Recruiting
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.
Led by Santen SAS · Updated on 2026-05-04
234
Participants Needed
36
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Able to understand and sign an informed consent form prior to participation in any studyrelated procedures.
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Male or female subjects ≥ 18 years and ≤ 75 years.
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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 of MRD1 will be done by a Central Reading Centre. If the centre of the pupil cannot be determined by the Central Reading Centre due to negative MRD1, the subject will be deemed ineligible.
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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 form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
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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 and beginning screening), or other contraception deemed adequate by the investigator during the study.
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Able to self-administer study treatment or to have the study treatment administered by a caregiver throughout the study period.
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An answer of 'Yes' to the question 'Does the ptosis cause enough burden to the subject to want to receive treatment for it'.
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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 ≥0 and ≤ 2 mm the more ptotic eye (the eye with the smaller MRD1 measurement) will be the study eye. If the MRD1 is the same in both eyes, the eye with the worse VF will be the study eye. If the MRD1 and VF is the same in both eyes, the right eye will be the study eye. The HVF Analyzer will determine if the visual field test is reliable. If the HVF Analyzer issues an "XX" for fixation losses, false positives, and/or false negatives, the test will be deemed unreliable. If deemed unreliable, the test must be retaken once per scheduled screening visit. If a reliable visual field cannot be obtained, the subject will be a screen failure.
You will not qualify if you...
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In either eye:
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Congenital ptosis.
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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.
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Neurogenic ptosis (e.g., Horner's syndrome, 3rd cranial nerve palsy).
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Myogenic ptosis.
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Marcus Gunn jaw-winking syndrome.
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Previous ptosis surgery (previous blepharoplasty is allowed provided the surgery took place at least 3 months prior to screening [Visit 1]).
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Lid position affected by lid or conjunctival scarring.
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Visual field loss from any cause other than ptosis.
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History of herpes keratitis.
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Poor fixation or abnormal eye position which prevents from taking reliable pictures for MRD1 measurement.
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History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed at least 3 months prior to screening (Visit 1).
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Facial including periocular neurotoxin (e.g., Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to screening (Visit 1) and during the study.
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Topical application of bimatoprost (i.e., Latisse®) to the eyelashes within 8 days prior to screening (Visit 1) and during the study.
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Mechanical ptosis e.g., ptosis due to orbital, corneal or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
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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 [e.g., antibiotics and antivirals], and anti-inflammatory drugs [including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids] within 8 days prior to screening (Visit 1) and during the study. Timolol maleate, or sympathetic alpha receptor agonists (e.g., brimonidine tartrate, or apraclonidine hydrochloride) for the treatment of elevated intraocular pressure. Please note that topical ophthalmic prostaglandin analogues for the treatment of elevated intraocular pressure are permitted if dosed in the evening in accordance with the approved prescribing information. All other topical antiglaucoma medications are prohibited.
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Any intravitreal injections (e.g., antiVEGFs, steroids) within 8 days prior to screening (Visit
1) and during the study.
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Current punctal plugs or placement of punctal plugs during the study.
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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, (artificial tears are allowed).
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Monoamine oxidase inhibitors (MAOI) (e.g., selegiline hydrochloride, rasagiline mesilate, safinamide mesilate).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 36 locations
1
Oftex.s.r.o, oční klinika
Pardubice, Czechia, 530 02
Actively Recruiting
2
Fakultni nemocnice Plzeň, Oční oddělení
Pilsen, Czechia
Actively Recruiting
3
Fakultni Thomayerova nemocnice
Prague, Czechia, 140 59
Actively Recruiting
4
Clinique Ophtalmologique Thiers
Bordeaux, France, 33100
Actively Recruiting
5
CHU Rennes - PONTCHAILLOU Service ophtalmologie
Guillon, France, 35000
Actively Recruiting
6
Hôpital Fondation Adolphe de Rothschild
Paris, France, 75019
Actively Recruiting
7
CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie
Saint-Etienne, France, 42055
Actively Recruiting
8
Unversitaetsmedizin Goettingen
Goettigen, Germany, 37075
Actively Recruiting
9
Universitätsmedizin Göttingen; Georg-August-Universität
Göttingen, Germany, 37075
Actively Recruiting
10
Budapest Retina Associates
Budapest, Hungary
Actively Recruiting
11
Budapesti Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
Budapest, Hungary
Actively Recruiting
12
Észak-Pesti Centrumkórház - Honvédkórház
Budapest, Hungary
Actively Recruiting
13
Debreceni Egyetem Klinikai Központ
Debrecen, Hungary
Actively Recruiting
14
Ganglion Orvosi Központ - Nozologen Kft.
Pécs, Hungary
Actively Recruiting
15
AOU di Ferrara, Arcispedale Sant'Anna
Ferrara, Italy, 44124
Actively Recruiting
16
AOU Federico II
Naples, Italy, 80131
Actively Recruiting
17
PU A. Gemelli, Università Cattolica del Sacro Cuore
Roma, Italy, 00168
Actively Recruiting
18
Leiden University Center (LUMC)
Leiden, Netherlands, 2333 ZA
Actively Recruiting
19
Oogziekenhuis Rotterdam
Rotterdam, Netherlands, 3011 BH
Actively Recruiting
20
Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM
Gdansk, Poland
Actively Recruiting
21
Gabinet Okulistyczny Prof. Edward Wylegala
Katowice, Poland, 40-594
Actively Recruiting
22
Centralny Szpital Kliniczny MSWiA w Warszawie, Oddzial Okulistyki
Warsaw, Poland, 02-507
Actively Recruiting
23
Military Institute of Medecine - National Institute of Research
Warsaw, Poland, 04-141
Actively Recruiting
24
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Actively Recruiting
25
Virgen de las Nieves University Hospital
Granada, Spain, 18014
Actively Recruiting
26
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
27
Hospital Universitario Ramón y Caja
Madrid, Spain, 28034
Actively Recruiting
28
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
29
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Actively Recruiting
30
Miguel Servet University Hospital
Zaragoza, Spain, 50009
Actively Recruiting
31
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
32
Moorfields Eye Hospital NHS Foundation Trust - Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Actively Recruiting
33
FaceRestoration Ltd
London, United Kingdom, W1G 8QL
Actively Recruiting
34
Opal Clinic London Ltd
London, United Kingdom, W8 5JN
Actively Recruiting
35
South tyneside & Sunderland NHS Trust, Sunderland Eye Infirmary
Sunderland, United Kingdom, SR2 9HP
Actively Recruiting
36
South Tyneside and Sunderland NHS Foundation Trust, Sunderland Eye Infirmary
Sunderland, United Kingdom
Actively Recruiting
Research Team
S
Santen SAS Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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