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
This is a randomised, double-masked, placebo-controlled Phase 3 study of the safety and efficacy of STN1013800 in the treatment of acquired blepharoptosis. Subjects diagnosed with acquired blepharoptosis who meet eligibility criteria at Visit 1 (Screening) will return within 8 days for Visit 2 (Baseline, Day 1). At Visit 2 (Baseline, Day 1) they will be randomised to receive double-masked treatment for 6 weeks, with study visits completed at Week 2 (Day 14) and Week 6 (Day 42), and a post-treatment visit completed 2 weeks (± 3 days) after last study drug administration. Approximately 234 adult subjects with blepharoptosis who meet all the eligibility criteria will be randomised in a 1:1 ratio to receive: * STN1013800 BID * Placebo BID Note that: * On study visits Day 1 and Day 42, the AM dose is administered at 08:00 (at site) and the PM dose is administered at 16:00 (self-administered at home) * On study visit Day 14, the AM dose is administered at 06:00 (self-administered at home), the PM dose is administered at 14:00 (at site)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
234
STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
Placebo (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
Time frame: Day 14 at 4 hours
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)
Time frame: Day 14 at 4 hours
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