Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05165290
Status:
UNKNOWN
Last Update Posted:
2022-05-25
First Post:
2021-12-17
Brief Title:
Prospective Double-masked Randomized Multi-center Active-controlled Parallel-group 3-month Study Assessing the Safety Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0005 in Subjects With Elevated Intraocular Pressure
Sponsor:
TearClear Corp
Organization:
TearClear Corp
Study Overview
Official Title:
Prospective Double-masked Randomized Multi-center Active-controlled Parallel-group 3-month Study Assessing the Safety Ocular Hypotensive Efficacy of TC-002 Ophthalmic Solution Compared to Latanoprost Ophthalmic Solution 0005 in Subjects With Elevated Intraocular Pressure
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
TC-002-301
Brief Summary:
Prospective double-masked randomized multi-center active-controlled parallel-group 3-month study assessing the safety and ocular hypotensive efficacy of TearClear latanoprost Ophthalmic Solution 0005 TC-002 compared to latanoprost Ophthalmic Solution 0005 LAT in subjects with elevated intraocular pressure at approximately 20 study sites located in the United States
Detailed Description:
This is a Phase 3 randomized investigator-masked multicenter parallel-group trial comparing two ophthalmic solution formulations of latanoprost at a fixed dose of 0005 administered once daily QD for 12 weeks
Approximately 300 subjects will be randomized in this study at approximately 20 sites in the United States US
Treatment assignments will be masked to TearClear study subjects Investigators and site staff Because the container closure for the investigational product is different this study will use an unmasked dosing coordinator at each study site All clinical trial supplies will be masked by using carton boxes to mask the appearance of the immediate container closure
At approximately 2 select sites approximately10 of total randomized subjects will have systemic PK labs drawn
The study involves 7 clinic visits including Screening Visit 1 Randomization Visit 2 and treatment visits Visits 3 5 and 7 during which ophthalmic assessments will occur and IOP will be assessed diurnally There will be two interim IP dispensation visits Visits 4 and 6
Approximately 300 subjects will be randomized in this study at approximately 20 sites in the United States US
Treatment assignments will be masked to TearClear study subjects Investigators and site staff Because the container closure for the investigational product is different this study will use an unmasked dosing coordinator at each study site All clinical trial supplies will be masked by using carton boxes to mask the appearance of the immediate container closure
At approximately 2 select sites approximately10 of total randomized subjects will have systemic PK labs drawn
The study involves 7 clinic visits including Screening Visit 1 Randomization Visit 2 and treatment visits Visits 3 5 and 7 during which ophthalmic assessments will occur and IOP will be assessed diurnally There will be two interim IP dispensation visits Visits 4 and 6
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?:
False
Is an FDA AA801 Violation?:
None