OXYMETAZOLINE HYDROCHLORIDE for Acquired blepharoptosis

Inclusion criteria

• {"criterion_text":"- 1.\tAble to understand and sign an informed consent form prior to participation in any study-related procedures.\n- 2.\tMale or female subjects ≥ 18 years.\n- 3.\tPresence of all the following at Screening: a.\tdiagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye b.\tSnellen 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\n- 4.\tFemales 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.\n- 5.\tA 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.\n- 6.\tAble to self-administer study treatment or to have the study treatment administered by a caregiver throughout the study period.\n- 7.\tAn answer of ‘Yes’ to the question ‘Does the ptosis cause enough burden to the subject to want to receive treatment for it’. \n- 8.\tLoss 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

• {"criterion_text":"- 1.\tCongenital ptosis.\n- 10.\tPoor fixation or abnormal eye position which prevents from taking reliable pictures for MRD1 measurement.\n- 11.\tHistory of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed at least 3 months prior to screening (Visit 1).\n- 12.\tFacial including periocular neurotoxin (e.g., Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to screening (Visit 1) and during the study.\n- 13.\tTopical application of bimatoprost (i.e., Latisse®) to the eyelashes within 8 days prior to screening (Visit 1) and during the study.\n- 14.\tMechanical ptosis e.g., ptosis due to orbital, corneal or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.\n- 15.\tUse 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\n- 16.\tAny intravitreal injections (e.g., antiVEGFs, steroids) within 8 days prior to screening (Visit 1) and during the study.\n- 17.\tCurrent punctal plugs or placement of punctal plugs during the study.\n- 18.\tCurrent 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).\n- 19.\tMonoamine oxidase inhibitors (MAOI) (e.g., selegiline hydrochloride, rasagiline mesilate, safinamide mesilate).\n- 2.\tPresence of either of the following: a.\tPseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or b.\tDermatochalasis that extends less than 3 mm above the upper eyelid margin.\n- 20.\tResting heart rate (HR) outside the normal range (50–100 beats per minute).\n- 21.\tHypertension with resting diastolic blood pressure (BP) > 105 mm Hg or systolic BP > 180 mm Hg\n- 22.\tUse of monoamine oxidase inhibitors (MAOIs; e.g., isocarboxazid, phenelzine, tranylcypromine) within 14 days prior to screening (Visit 1) and during the study.\n- 23.\tMyasthenia gravis.\n- 24.\tAdvanced arteriosclerotic disease or history of cerebrovascular accident (CVA).\n- 25.\tHistory 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.\n- 26.\tSubjects 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.\n- 27.\tPregnancy or lactation.\n- 28.\tDiagnosed benign prostatic hypertrophy requiring medicinal therapy; previous prostatectomy is allowed.\n- 29.\tHistory 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.).\n- 3.\tNeurogenic ptosis (e.g., Horner’s syndrome, 3rd cranial nerve palsy).\n- 30.\tParticipation in any drug or device clinical investigation within 30 days prior to screening (Visit 1) and/or during the period of study participation.\n- 31.\tPlanned use of prohibited concomitant medications during study.\n- 32.\tPresence 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.).\n- 33.\tAbuse or dependence of alcohol or drugs.\n- 34.\tAny decision by the Investigator or Medical Monitor to terminate a subject in screening or declare any subject ineligible for any sound medical reason.\n- 4.\tMyogenic ptosis.\n- 5.\tMarcus Gunn jaw-winking syndrome.\n- 6.\tPrevious ptosis surgery (previous blepharoplasty is allowed provided the surgery took place at least 3 months prior to screening [Visit 1]).\n- 7.\tLid position affected by lid or conjunctival scarring.\n- 8.\tVisual field loss from any cause other than ptosis.\n- 9.\tHistory of herpes keratitis."}

Primary endpoints

• {"endpoint_text":"- Change from baseline in MRD1 on Day 14","definition_or_measurement_approach":"MRD1 is defined as the distance between upper eye lid margin and centre of the pupil. MRD1 measurement will be done by a Central Reading Centre; if the centre of the pupil cannot be determined due to negative MRD1 the subject is ineligible."}

Secondary endpoints

• {"endpoint_text":"- PRO: PGIC on Day 14","definition_or_measurement_approach":"Patient-Reported Outcome: Patient Global Impression of Change (PGIC) assessed on Day 14 (PRO instrument/questionnaire specified in protocol)."}

Methods

• Country-specific recruitment websites (documents titled 'Recruitment Website' present for multiple countries: Czechia, Hungary, Poland, France, Spain, Italy, Netherlands).
• Country-specific recruitment brochures (documents titled 'Recruitment Brochure' present for multiple countries).
• Recruitment Procedure Description documents (K1) / Recruitment arrangements (country-specific) describing local site recruitment procedures and informed consent process.
• Recruitment brochures/web content presumably targeted to potential patient participants (materials exist in country languages).

Germany

Earliest CTIS Part Ii Submission Date

07-11-2024

Latest Decision Or Authorization Date

14-10-2025

Processing Time Days

341

Number Of Sites

1

Number Of Participants

10

Czechia

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

355

Number Of Sites

4

Number Of Participants

60

Hungary

Earliest CTIS Part Ii Submission Date

20-08-2024

Latest Decision Or Authorization Date

19-11-2025

Processing Time Days

456

Number Of Sites

8

Number Of Participants

41

Poland

Earliest CTIS Part Ii Submission Date

21-10-2024

Latest Decision Or Authorization Date

17-10-2025

Processing Time Days

361

Number Of Sites

5

Number Of Participants

50

France

Earliest CTIS Part Ii Submission Date

20-08-2024

Latest Decision Or Authorization Date

14-10-2025

Processing Time Days

420

Number Of Sites

3

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

11-11-2024

Latest Decision Or Authorization Date

14-10-2025

Processing Time Days

337

Number Of Sites

4

Number Of Participants

40

Italy

Earliest CTIS Part Ii Submission Date

20-08-2024

Latest Decision Or Authorization Date

16-10-2025

Processing Time Days

422

Number Of Sites

3

Number Of Participants

30

Netherlands

Earliest CTIS Part Ii Submission Date

07-11-2024

Latest Decision Or Authorization Date

04-12-2025

Processing Time Days

392

Number Of Sites

4

Number Of Participants

30

Primary sponsor

Full Name

Santen

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Qualification, initiation, monitoring, auditing, and closure of investigational sites and Clinical Trial conclusion (sponsorDuties codes include 1,12,15,5,6).

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Codes: 1,12,15 (Qualification, initiation, monitoring, auditing, and closure of investigational sites and Clinical Trial conclusion),5,6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement (code:15)","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Italy","full_name":"SBM SISTEMI SRL","duties_or_roles":"code:4","organisation_type":"Industry"}
• {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations, PRO Licensing, Labelling, Redaction (code:15)","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Clinigen Clinical Supplies Management","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}