Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514612
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
LIDRISE Study A Phase 3 Study on the Efficacy and Safety of STN1013800 Oxymetazoline HCl 01 Eye Drops Single Dose in the Treatment of Acquired Blepharoptosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Double-Masked Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 Oxymetazoline HCl 01 Eye Drops Used Twice Daily BID in the Treatment of Acquired Blepharoptosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 01 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 11 ratio to receive
STN1013800 BID
Placebo BID
Note that
On study visits Day 1 and Day 42 the AM dose is administered at 0800 at site and the PM dose is administered at 1600 self-administered at home
On study visit Day 14 the AM dose is administered at 0600 self-administered at home the PM dose is administered at 1400 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 11 ratio to receive
STN1013800 BID
Placebo BID
Note that
On study visits Day 1 and Day 42 the AM dose is administered at 0800 at site and the PM dose is administered at 1600 self-administered at home
On study visit Day 14 the AM dose is administered at 0600 self-administered at home the PM dose is administered at 1400 at site
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None