Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837482
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2021-04-06
Brief Title:
A Study to Assess the Impact and Adverse Events of Topical Eyedrops of AGN-190584 on Night-driving Performance in Participants 40 to 55 Years of Age
Sponsor:
Allergan
Organization:
Allergan
Study Overview
Official Title:
Evaluating the Impact of AGN-190584 on Night-driving Performance
Status:
COMPLETED
Status Verified Date:
2024-09
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:
TAURUS
Brief Summary:
The purpose of this study is to evaluate night-driving performance in real-world driving conditions in participants with presbyopia treated with AGN-190584 versus vehicle Adverse events and change in disease symptoms will be assessed
AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical once-daily eyedrop delivered by a proprietary vehicle
This crossover study consists of two parts Part 1 consists of Visit 2 and Visit 3 and Part 2 consists of Visit 4 and Visit 5 Approximately half of the participants will receive AGN-190584 at Visit 2 through Visit 3 Sequence 1 participants and the remaining participants Sequence 2 participants will receive AGN-190584 at Visit 4 through Visit 5 All participants will receive AGN-190584 at home as instructed Approximately 54 adult participants with presbyopia will be enrolled at 1 site in Australia
Treatment duration is expected to be no more than 71 days In Part 1 at Visit 2 Day 1 and at home as instructed for 7 to 14 days Sequence 1 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each eye All participants will have a driving assessment at Visit 3 Day 8 to 15 In Part 2 at Visit 4 Day 15 to 57 and at home as instructed for 7 to 14 days Sequence 2 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1 eyedrop of vehicle in each eye All participants will have a driving assessment at Visit 5 Day 22 to 71
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the course of the study at a hospital or clinic The effects of the treatment will be checked by medical assessments asking about side effects and completing questionnaires
AGN-190584 is an investigational formulation of pilocarpine for treating symptoms associated with presbyopia as a topical once-daily eyedrop delivered by a proprietary vehicle
This crossover study consists of two parts Part 1 consists of Visit 2 and Visit 3 and Part 2 consists of Visit 4 and Visit 5 Approximately half of the participants will receive AGN-190584 at Visit 2 through Visit 3 Sequence 1 participants and the remaining participants Sequence 2 participants will receive AGN-190584 at Visit 4 through Visit 5 All participants will receive AGN-190584 at home as instructed Approximately 54 adult participants with presbyopia will be enrolled at 1 site in Australia
Treatment duration is expected to be no more than 71 days In Part 1 at Visit 2 Day 1 and at home as instructed for 7 to 14 days Sequence 1 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 2 participants will receive 1 eyedrop of vehicle in each eye All participants will have a driving assessment at Visit 3 Day 8 to 15 In Part 2 at Visit 4 Day 15 to 57 and at home as instructed for 7 to 14 days Sequence 2 participants will receive 1 eyedrop of AGN-190584 in each eye and Sequence 1 participants will receive 1 eyedrop of vehicle in each eye All participants will have a driving assessment at Visit 5 Day 22 to 71
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the course of the study at a hospital or clinic The effects of the treatment will be checked by medical assessments asking about side effects and completing questionnaires
Detailed Description:
None
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