Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369077
Status:
TERMINATED
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
How Much Does Reduced Dosing of Latanoprost and Dorzolamide-timolol Affect Pressure
Sponsor:
CT Glaucoma Associates
Organization:
CT Glaucoma Associates
Study Overview
Official Title:
Cross-over Comparison of Latanoprost QOD With Dor-tim QAM to Tim-brim-dor-bimAtoprost qd or Lat QD With Dor-tim BID
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The 95 confidence interval for non-inferiority was met before planned enrollment was reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IOP effect of half-dose latanoprost dorzolamide-timolol will be compared to full dose Further comparison will be made timolol-brimonidine-dorzolamide-bimatoprost Dry eye effects of the different treatments will be assessed
Detailed Description:
Subjects will have baseline IOP measurements 7-9 am and 3-5 pm after using using latanoprost every other day and dorzolamide-timolol every morning They will then randomly be assigned in phase 2 to either double the frequency to latanoprost daily and dorzolamide-timolol twice daily or use every morning compounded timolol-brimonidine-dorzolamide-bimatoprost IOP measurements will be repeated 3 weeks after using the phase 2 medications For phase 3 subjects will use the treatment to which they were not assigned in phase 2 and IOP measurements will again be repeated 3 weeks later
At each study visit dry eye signs will be assessed and brief dry eye survey will be administered
At each study visit dry eye signs will be assessed and brief dry eye survey will be administered
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?:
True
Is an FDA AA801 Violation?:
None