Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 8:05 AM
Study NCT ID:
NCT06514612
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Santen SAS
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: