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

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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:

‣ 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.

• 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.

Locations
Other Locations
France
Clinique Ophtalmologique Thiers
RECRUITING
Bordeaux
CHU Rennes - PONTCHAILLOU Service ophtalmologie
RECRUITING
Guillon
Hôpital Fondation Adolphe de Rothschild
RECRUITING
Paris
CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie
RECRUITING
Saint-etienne
Germany
Unversitaetsmedizin Goettingen
NOT_YET_RECRUITING
Goettigen
Universitätsmedizin Göttingen; Georg-August-Universität
RECRUITING
Göttingen
Hungary
Budapest Retina Associates
RECRUITING
Budapest
Budapesti Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
RECRUITING
Budapest
Észak-Pesti Centrumkórház - Honvédkórház
RECRUITING
Budapest
Debreceni Egyetem Klinikai Központ
RECRUITING
Debrecen
Ganglion Orvosi Központ - Nozologen Kft.
RECRUITING
Pécs
Italy
AOU di Ferrara, Arcispedale Sant'Anna
RECRUITING
Ferrara
AOU Federico II
RECRUITING
Napoli
PU A. Gemelli, Università Cattolica del Sacro Cuore
RECRUITING
Roma
Netherlands
Leiden University Center (LUMC)
RECRUITING
Leiden
Oogziekenhuis Rotterdam
NOT_YET_RECRUITING
Rotterdam
Poland
Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM
RECRUITING
Gdansk
Gabinet Okulistyczny Prof. Edward Wylegala
NOT_YET_RECRUITING
Katowice
Centralny Szpital Kliniczny MSWiA w Warszawie, Oddzial Okulistyki
RECRUITING
Warsaw
Military Institute of Medecine - National Institute of Research
NOT_YET_RECRUITING
Warsaw
Military Institute of Medecine - National Institute of Research, Oddzial Okulistyki
NOT_YET_RECRUITING
Warsaw
Spain
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Virgen de las Nieves University Hospital
NOT_YET_RECRUITING
Granada
Hospital Universitario Ramón y Caja
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
RECRUITING
Madrid
Complexo Hospitalario Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Miguel Servet University Hospital
RECRUITING
Zaragoza
United Kingdom
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
RECRUITING
Leeds
FaceRestoration Ltd
NOT_YET_RECRUITING
London
Moorfields Eye Hospital NHS Foundation Trust - Moorfields Eye Hospital
NOT_YET_RECRUITING
London
Opal Clinic London Ltd
NOT_YET_RECRUITING
London
South tyneside & Sunderland NHS Trust, Sunderland Eye Infirmary
RECRUITING
Sunderland
South Tyneside and Sunderland NHS Foundation Trust, Sunderland Eye Infirmary
RECRUITING
Sunderland
Contact Information
Primary
Santen SAS Clinical Operations
edith.vandijkman@santen.com
+31 683 667 357
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 234
Treatments
Experimental: STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
Placebo_comparator: Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers
Related Therapeutic Areas
Sponsors
Leads: Santen SAS

This content was sourced from clinicaltrials.gov