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
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.
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.
Congenital ptosis.
Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or
Dermatochalasis that extends less than 3 mm above the upper eyelid margin.
Neurogenic ptosis (e.g., Horner's syndrome, 3rd cranial nerve palsy).
Parallel
STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
DrugSTN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers
Other interventionPlacebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers
Change from baseline in Marginal Reflex Distance (MRD1) on Day 14 at 4 hours after PM dose.
Change from baseline in MRD1 (Marginal Reflex Distance, Distance from the centre of the pupil to central upper lid margin) on Day 14 at 4 hours after PM dose. This is to evaluate the efficacy of STN1013800 dosed twice daily in the treatment of acquired blepharoptosis on Day 14
PRO (Patient Reported Outcome): PGIC (Subject Global Impression of Change) on Day 14, 4 hours after PM dose
To assess the degree of improvement experienced by subjects since start of the trial (PRO)
