Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06267274
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-02-12
Brief Title:
A Randomized Double-blind Parallel-group Two-arm Multiple Dose Multicenter Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
Sponsor:
Amneal Pharmaceuticals LLC
Organization:
Amneal Pharmaceuticals LLC
Study Overview
Official Title:
A Randomized Double-blind Parallel-group Two-arm Multiple Dose Multicenter Bioequivalence Study With Clinical Endpoint Comparing Generic Bimatoprost Ophthalmic Solution 001 and LUMIGAN Bimatoprost Ophthalmic Solution 001 in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
Status:
RECRUITING
Status Verified Date:
2024-08
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:
A randomized double-blind parallel-group two-arm multiple dose multicenter clinical endpoint bioequivalence study
Detailed Description:
Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes who meet all of the inclusion criteria and none of the exclusion criteria will be identified
Potential subjects will be screened within 6 weeks prior to administration of the first drop of study drug They will undergo a washout period of 4 days to 4 weeks 28 days based on their current medication if available Based on stratification criteria IOP and CCT information available at baseline visit for each subject the subjects will be randomized in such way that ratio of treatment distribution will be nearer to 11 between the treatment arms and within the combined stratification criteria The Primary Endpoint is mean difference in the IOP of both eyes between the two treatment groups at 3 time points ie at 0000 hour 0400 hours 4 hours 1 hour after 0000 hour and 0800 hours 8 hours 1 hour after 0000 hour at Day 14 Week 2 4 days and Day 42 Week 6 4 days visits
The Secondary Endpoint the incidence of all adverse events reported during the study will be summarized by treatment group Test and reference products will be compared for safety by analyzing nature severity and frequency of treatment emergent adverse events
Potential subjects will be screened within 6 weeks prior to administration of the first drop of study drug They will undergo a washout period of 4 days to 4 weeks 28 days based on their current medication if available Based on stratification criteria IOP and CCT information available at baseline visit for each subject the subjects will be randomized in such way that ratio of treatment distribution will be nearer to 11 between the treatment arms and within the combined stratification criteria The Primary Endpoint is mean difference in the IOP of both eyes between the two treatment groups at 3 time points ie at 0000 hour 0400 hours 4 hours 1 hour after 0000 hour and 0800 hours 8 hours 1 hour after 0000 hour at Day 14 Week 2 4 days and Day 42 Week 6 4 days visits
The Secondary Endpoint the incidence of all adverse events reported during the study will be summarized by treatment group Test and reference products will be compared for safety by analyzing nature severity and frequency of treatment emergent adverse events
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