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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Santen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

30 Dec 2024 → ongoing

Decision date (initial)

2024-11-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the efficacy of STN1013800 dosed twice daily in the treatment of acquired blepharoptosis on Day 14.

Secondary objectives 1

1. To assess the degree of improvement experienced by subjects since start of the trial (PRO)

Conditions and MedDRA coding

Acquired Blepharoptosis

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices, Medicines Evaluation Board, Spanish Agency For Medicines And Health Products, European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. 1. Able to understand and sign an informed consent form prior to participation in any study-related procedures.
2. 2. Male or female subjects ≥ 18 years.
3. 3. Presence of all the following at Screening: a. diagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye b. 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
4. 4. 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.
5. 5. 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.
6. 6. Able to self-administer study treatment or to have the study treatment administered by a caregiver throughout the study period.
7. 7. An answer of ‘Yes’ to the question ‘Does the ptosis cause enough burden to the subject to want to receive treatment for it’.
8. 8. 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.

Exclusion criteria 34

1. 1. Congenital ptosis.
2. 2. Presence of either of the following: a. Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or b. Dermatochalasis that extends less than 3 mm above the upper eyelid margin.
3. 3. Neurogenic ptosis (e.g., Horner’s syndrome, 3rd cranial nerve palsy).
4. 4. Myogenic ptosis.
5. 5. Marcus Gunn jaw-winking syndrome.
6. 6. Previous ptosis surgery (previous blepharoplasty is allowed provided the surgery took place at least 3 months prior to screening [Visit 1]).
7. 7. Lid position affected by lid or conjunctival scarring.
8. 8. Visual field loss from any cause other than ptosis.
9. 9. History of herpes keratitis.
10. 10. Poor fixation or abnormal eye position which prevents from taking reliable pictures for MRD1 measurement.
11. 11. History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed at least 3 months prior to screening (Visit 1).
12. 12. Facial including periocular neurotoxin (e.g., Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to screening (Visit 1) and during the study.
13. 13. Topical application of bimatoprost (i.e., Latisse®) to the eyelashes within 8 days prior to screening (Visit 1) and during the study.
14. 14. Mechanical ptosis e.g., ptosis due to orbital, corneal or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
15. 15. 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 anti-glaucoma medications are prohibited
16. 16. Any intravitreal injections (e.g., antiVEGFs, steroids) within 8 days prior to screening (Visit 1) and during the study.
17. 17. Current punctal plugs or placement of punctal plugs during the study.
18. 18. 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).
19. 19. Monoamine oxidase inhibitors (MAOI) (e.g., selegiline hydrochloride, rasagiline mesilate, safinamide mesilate).
20. 20. Resting heart rate (HR) outside the normal range (50–100 beats per minute).
21. 21. Hypertension with resting diastolic blood pressure (BP) > 105 mm Hg or systolic BP > 180 mm Hg
22. 22. Use of monoamine oxidase inhibitors (MAOIs; e.g., isocarboxazid, phenelzine, tranylcypromine) within 14 days prior to screening (Visit 1) and during the study.
23. 23. Myasthenia gravis.
24. 24. Advanced arteriosclerotic disease or history of cerebrovascular accident (CVA).
25. 25. History of hyperthyroidism or thyroid eye disease (i.e., exophthalmos, upper eyelid retraction, diplopia secondary to extraocular muscle involvement). Hypothyroidism that is controlled on medication is allowed.
26. 26. Subjects with proliferative diabetic retinopathy may not be enrolled. However, subjects with insulin dependent diabetes, diabetes requiring oral hypoglycemic drugs, or diet-controlled diabetes are allowed.
27. 27. Pregnancy or lactation.
28. 28. Diagnosed benign prostatic hypertrophy requiring medicinal therapy; previous prostatectomy is allowed.
29. 29. History of contact or systemic allergic reaction to oxymetazoline hydrochloride or other sympathomimetic drugs (e.g., phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, fepradinol, or methoxamine, or any other diagnostic drugs intended to be used during the study period (e.g., Fluorescein, tropicamide etc.).
30. 30. Participation in any drug or device clinical investigation within 30 days prior to screening (Visit 1) and/or during the period of study participation.
31. 31. Planned use of prohibited concomitant medications during study.
32. 32. Presence or history of any disease or condition that in the opinion of the Investigator may put the subject at significant risk or may confound study results or may interfere significantly with the subject’s participation in the study (e.g., uncontrolled cardiovascular disease, severe cardiovascular, respiratory, hepatobiliary, gastrointestinal, urology, renal, hematological, endocrine, immune, malignancy etc.).
33. 33. Abuse or dependence of alcohol or drugs.
34. 34. Any decision by the Investigator or Medical Monitor to terminate a subject in screening or declare any subject ineligible for any sound medical reason.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change from baseline in MRD1 on Day 14

Secondary endpoints 1

1. PRO: PGIC on Day 14

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Santen

Sponsor organisation

Santen

Address

Tour W, 102 Terrasse Boieldieu 102 Terrasse Boieldieu

City

Puteaux

Postcode

92800

Country

France

Scientific contact point

Organisation

Santen

Contact name

Senior Medical Director

Public contact point

Organisation

Santen

Contact name

Vice President, PPD Operational Excellence and Chief of Staff

Third parties 6

Locations

8 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 77 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications