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A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses

NCT03897751 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-03-03

Study results available
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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.

Conditions

  • Contact Lens Wear

Interventions

DEVICE

ABT12 Multi-Purpose Solution

Contact lens cleaning and disinfecting solution

DEVICE

COMPLETE Multi-Purpose Solution

Contact lens cleaning and disinfecting solution

DEVICE

Sensitive Eyes® Rewetting Drops

For use as needed during the study.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Johnson Varughese · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2019-08-01
Completion
2019-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897751 on ClinicalTrials.gov