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A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution

NCT05565937 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2025-05-20

Study results available
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Summary

Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.

Conditions

  • Refractive Ametropia

Interventions

DEVICE

BL-3100-NBR03 multi-purpose solution

BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses

DEVICE

renu® Advanced Formula multi-purpose solution

renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Daniel Donatello · 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
2023-04-12
Primary Completion
2024-02-28
Completion
2024-02-28
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 NCT05565937 on ClinicalTrials.gov