Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06514612

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and sign an informed consent form prior to participation in any studyrelated procedures.

  • Male or female subjects ≥ 18 years and ≤ 75 years.

  • Presence of all the following at Screening:

    1. diagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye
    2. 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.
  • 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.

  • 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.

  • 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 ≥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.

Not Eligible

You will not qualify if you...

  • In either eye:

  • Congenital ptosis.

  • Presence of either of the following:

    1. Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or
    2. 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 [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.

  • 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, (artificial tears are allowed).

  • 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

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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

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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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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. | DecenTrialz