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

NCT05565937 | Completed Results FDA Device

• 1 other identifier: 914
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 19

Brief 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

Outcome Measures

Primary Outcomes (4)

• Overall Comfort Averaged Over All Follow-up Visits

  Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response

  Assessed at all follow-up visits through 3 months.

• Vision Averaged Over All Follow-up Visits

  Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response

  Assessed at all follow-up visits through 3 months.

• The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits.

  The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface. 1. \- Very slight, only visible after tear film drying. 2. \- Slight, visible deposits easily removable. 3. \- Moderate, deposits adherent and not removable. 4. \- Severe, non-removable deposits and comfort affected.

  Assessed at all follow-up visits through 3 months.

• The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.

  Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4.

  Assessed at 3 months

Study Arms (2)

BL-3100-NBR03

EXPERIMENTAL

BL-3100-NBR03 multi-purpose solution

Device: BL-3100-NBR03 multi-purpose solution

renu® Advanced Formula

ACTIVE COMPARATOR

renu® Advanced Formula multi-purpose solution

Device: renu® Advanced Formula multi-purpose solution

Interventions

BL-3100-NBR03 multi-purpose solution DEVICE

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

BL-3100-NBR03

renu® Advanced Formula multi-purpose solution DEVICE

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

renu® Advanced Formula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed
• Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations
• Is a habitual wearer (at least 3 months)
• Has typically cleaned and disinfected their pre-study contact lenses daily
• Must have spectacle correctable distance visual acuity through spherocylindrical refraction to 40 letters (0.14 logarithm of the minimal angle of resolution (logMAR) or better in each eye, at 2 meters distance with high contrast chart
• Has clear central corneas and is free of any anterior segment disorders
• Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses
• Requires lens correction in both eyes
• Wears the same manufacturer and brand of lens in both eyes
• Agrees to wear study lenses on a daily wear basis for approximately three months
• Is willing and able to comply with all treatment and follow-up/study procedures.

You may not qualify if:

• Is currently using a hydrogen-peroxide cleaning and disinfecting solution
• Participated in any drug or device clinical investigation within 30 days prior to entry into this study
• Is a female of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following conditions:
• they are currently pregnant
• they plan to become pregnant during the study
• they are breastfeeding
• Has worn gas permeable (GP) lenses within the last 30 days
• Has worn polymethylmethacrylate (PMMA) lenses within the last three months
• Has typically worn their pre-study contact lenses on an extended wear basis, sleeping in their lenses one night or more per week, during the last year
• Has any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study
• Subjects with an active ocular disease, or who are using any ocular medication.
• Is using any medications that will, in the Investigator's opinion, affect ocular physiology or lens performance
• Currently wears monovision, multifocal, or toric contact lenses
• Has ocular astigmatism of 1.00D or greater in either eye
• Has anisometropia (spherical equivalent) of greater than 2.00D

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (19)

Eric White OD Inc

San Diego, California, 92123, United States

Location

Lee & Woo Optometry

San Francisco, California, 94112, United States

Location

Chester T Roe III MD Prof LLC

Denver, Colorado, 80246, United States

Location

Eola Eyes

Orlando, Florida, 32803, United States

Location

Golden Vision

Sarasota, Florida, 34237, United States

Location

The Eyecare Studio, LLC

Decatur, Georgia, 30035, United States

Location

Kannarr EyeCare

Pittsburg, Kansas, 66762, United States

Location

Casco Bay EyeCare

Portland, Maine, 04101, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Advanced Eye Care, PC

Raytown, Missouri, 64133, United States

Location

Koetting Associates

St Louis, Missouri, 63144, United States

Location

InSight Eyecare

Warrensburg, Missouri, 64093, United States

Location

Berlin Eyecare Associates

West Berlin, New Jersey, 08091, United States

Location

Spectrum Eyecare

Jamestown, New York, 14701, United States

Location

Saccco Eye Group

Vestal, New York, 13850, United States

Location

Oculus Research

Raleigh, North Carolina, 27603, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Optometric Physicians of Middle Tennessee

Nashville, Tennessee, 37205, United States

Location

Biopharma Informatic

Houston, Texas, 77043, United States

Location

Results Point of Contact

• Title: Daniel Donatello
• Organization: Bausch & Lomb

Daniel.Donatello@bausch.com

5853385306

Study Officials

• Daniel Donatello

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: April 12, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 20, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-05

Locations

US (19)