Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06030193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2023-08-18
Brief Title:
Qlaris Phase 2 Study in NTG Patients
Sponsor:
Qlaris Bio Inc
Organization:
Qlaris Bio Inc
Study Overview
Official Title:
A Randomized Vehicle-controlled Double-masked Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Subjects With Normal Tension Glaucoma NTG
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
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:
Qlaris Phase 2 clinical trial investigating the safety tolerability and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients
Detailed Description:
A randomized active- and vehicle-controlled multi-site double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with NTG Primary objective is to evaluate the ocular and systemic safety and tolerability of 2 concentrations of QLS-111 compared to vehicle control
Secondary objective is to evaluate the ocular hypotensive efficacy of 2 concentrations of QLS-111 with once daily morning QAM once daily evening QPM and twice daily BID dosing versus vehicle with QAM QPM and BID dosing
Secondary objective is to evaluate the ocular hypotensive efficacy of 2 concentrations of QLS-111 with once daily morning QAM once daily evening QPM and twice daily BID dosing versus vehicle with QAM QPM and BID dosing
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Nightingale | OTHER | Qlaris Bio Inc | None |