Ignite Creation Date:
2024-05-06 @ 1:01 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03918915
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2019-04-12
Brief Title:
The Safety and Efficacy of SYD-101 in Children With Myopia
Sponsor:
Sydnexis Inc
Organization:
Sydnexis Inc
Study Overview
Official Title:
A Multicenter Randomized Double-masked Vehicle-controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
STAR
Brief Summary:
Myopia or nearsightedness is the most common eye disorder often affecting more than 40 of adults in Europe Asia and the USA Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma cataracts and retinal detachment which may lead to blindness Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life This study investigates the use of SYD-101 an eye solution in slowing-down the progression of myopia in children
Detailed Description:
This will be a 5-arm multicentered randomized double-masked vehicle-controlled study conducted in 2 parts
Part 1 is the primary treatment period of 3 years during which participants will receive 1 of 3 masked medications
Part 2 is the randomized withdrawal period of 1 year during which participants originally receiving Vehicle will receive SYD-101 and participants originally receiving SYD-101 will receive either Vehicle or SYD-101
Part 1 is the primary treatment period of 3 years during which participants will receive 1 of 3 masked medications
Part 2 is the randomized withdrawal period of 1 year during which participants originally receiving Vehicle will receive SYD-101 and participants originally receiving SYD-101 will receive either Vehicle or SYD-101
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None