Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04890106
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2021-05-12
Brief Title:
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 001 to LUMIGAN In The Treatment of Chronic Open-Angle Glaucoma
Sponsor:
Mankind Pharma Limited
Organization:
Mankind Pharma Limited
Study Overview
Official Title:
A Randomized 11 Double-Masked Multi-Center Two-Treatment Single-Period Parallel Design Mutiple Dose Bioequivalence Study With Clinical End-Point of Bimatoprost Ophthalmic Solution 001 of Mankind Pharma Limited With LUMIGAN Bimatoprost Ophthalmic Solution 001 of Allergan Inc in Subjects With Chronic Open-Angle Glaucoma Or Ocular Hypertension in Both Eyes
Status:
COMPLETED
Status Verified Date:
2022-12
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:
Glaucoma
Brief Summary:
This is a randomized double-masked two-treatment single-period parallel design multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes
Test Product - Bimatoprost Ophthalmic Solution 001 of Mankind Pharma Limited India
Reference Product - LUMIGAN Bimatoprost Ophthalmic Solution 001 of Allergan Inc
Test Product - Bimatoprost Ophthalmic Solution 001 of Mankind Pharma Limited India
Reference Product - LUMIGAN Bimatoprost Ophthalmic Solution 001 of Allergan Inc
Detailed Description:
Subjects with chronic open-angle glaucoma or ocular hypertension in both the eyes and meeting all the mentioned inclusion criteria and none of the exclusion criteria will be identified Qualifying Intra Ocular Pressure IOPs following wash-out at baseline Day 0 at anytime of the day should be 22 milli meter mercury mm Hg and 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg
Subjects will receive one drop of investigational product either A or B in both the eyes every evening at approximately 1000 pm 2 hours for 42 days
The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety Study subject primary endpoint evaluation will be assessed after 2 weeks day 14 and 6 weeks Day 42 of treatment for each study subject deemed eligible for evaluation
The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure IOP of both eyes between the two treatment groups at six time points ie at 0000 hours between 800am and 1000 am 0400 hours at 4 hours after 0000 hours and 0800 hours at 8 hours after 0000 hours on Day 14 week 2 and Day 42 week 6 visits
Subjects will receive one drop of investigational product either A or B in both the eyes every evening at approximately 1000 pm 2 hours for 42 days
The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety Study subject primary endpoint evaluation will be assessed after 2 weeks day 14 and 6 weeks Day 42 of treatment for each study subject deemed eligible for evaluation
The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure IOP of both eyes between the two treatment groups at six time points ie at 0000 hours between 800am and 1000 am 0400 hours at 4 hours after 0000 hours and 0800 hours at 8 hours after 0000 hours on Day 14 week 2 and Day 42 week 6 visits
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