Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-29 @ 6:35 AM
Study NCT ID:
NCT03897751
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses
Sponsor:
Bausch & Lomb Incorporated
Organization:
Study Overview
Official Title:
A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution
Status:
COMPLETED
Status Verified Date:
2023-03
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:
This study is to evaluate the safety and effectiveness of ABT12 Multi-Purpose solution (Test) compared to COMPLETE® Multi-Purpose Solution Easy Rub® Formula ("COMPLETE Multi-Purpose Solution") when used by participants who are habitual contact lens wearers.
Detailed Description:
Eligible participants will be enrolled from 1 of 5 lens groups based on their habitual contact lenses. Participants will be randomized on a 1:1 basis within each group per site to receive either ABT12 Multi-Purpose solution or COMPLETE Multi-Purpose Solution. The 5 lens groups will be comprised of habitual wearers of soft lenses based on the following lens material:
* Etaficon A, Acuvue2, Vistakon
* Balafilcon A, PureVision2, Bausch + Lomb
* Samfilcon A, Ultra, Bausch + Lomb
* Lotrafilcon B, Optix Aqua, Alcon
* Senofilcon C, Vita, Vistakon
* Etaficon A, Acuvue2, Vistakon
* Balafilcon A, PureVision2, Bausch + Lomb
* Samfilcon A, Ultra, Bausch + Lomb
* Lotrafilcon B, Optix Aqua, Alcon
* Senofilcon C, Vita, Vistakon
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: