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

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

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.

Study Overview

• Status: Completed
• Conditions: Refractive Ametropia
• Intervention / Treatment: Device: BL-3100-NBR03 multi-purpose solution; Device: renu® Advanced Formula multi-purpose solution

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Donatello; Phone Number: 5853385306; Email: Daniel.Donatello@bausch.com

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Eric White OD Inc
    • San Francisco, California, United States, 94112
      • Lee & Woo Optometry
  • Colorado
    • Denver, Colorado, United States, 80246
      • Chester T Roe III MD Prof LLC
  • Florida
    • Jacksonville, Florida, United States, 32246
      • Pearle Vision
    • Sarasota, Florida, United States, 34237
      • Golden Vision
  • Georgia
    • Decatur, Georgia, United States, 30035
      • The Eyecare Studio, LLC
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr EyeCare
  • Maine
    • Portland, Maine, United States, 04101
      • Casco Bay EyeCare
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • Koetting Associates
  • New York
    • Jamestown, New York, United States, 14701
      • Spectrum Eyecare
    • Vestal, New York, United States, 13850
      • Saccco Eye Group
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • Oculus Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
    • Nashville, Tennessee, United States, 37205
      • Optometric Physicians of Middle Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed
2. 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
3. Is a habitual wearer (at least 3 months)
4. Has typically cleaned and disinfected their pre-study contact lenses daily
5. 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
6. Has clear central corneas and is free of any anterior segment disorders
7. Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses
8. Requires lens correction in both eyes
9. Wears the same manufacturer and brand of lens in both eyes
10. Agrees to wear study lenses on a daily wear basis for approximately three months
11. Is willing and able to comply with all treatment and follow-up/study procedures.

Exclusion Criteria:

1. Is currently using a hydrogen-peroxide cleaning and disinfecting solution
2. Participated in any drug or device clinical investigation within 30 days prior to entry into this study

3. 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
4. Has worn gas permeable (GP) lenses within the last 30 days
5. Has worn polymethylmethacrylate (PMMA) lenses within the last three months
6. 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
7. 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
8. Subjects with an active ocular disease, or who are using any ocular medication.
9. Is using any medications that will, in the Investigator's opinion, affect ocular physiology or lens performance
10. Currently wears monovision, multifocal, or toric contact lenses
11. Has ocular astigmatism of 1.00D or greater in either eye
12. Has anisometropia (spherical equivalent) of greater than 2.00D
13. Has any grade 2 or greater finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation)
14. Has corneal infiltrates, of ANY GRADE
15. Has any "Present" ungraded finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation) that, in the Investigator's judgment, interferes with contact lens wear.
16. Has typically worn their pr-study control lenses on an extended wear bases, sleeping on their lenses one night or more per week, during the last year.
17. Is aphakic
18. Is amblyopic
19. Has had any corneal surgery (e.g., refractive surgery)
20. Is allergic to any component in the study care products.
21. Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee's household
22. Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties
23. Is an employee of a manufacturer of contact lenses or contact lens care products (e.g., Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, Johnson & Johnson, etc.) or currently resides with a person employed by any of these manufacturers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BL-3100-NBR03; BL-3100-NBR03 multi-purpose solution	Device: BL-3100-NBR03 multi-purpose solution; BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
Active Comparator: renu® Advanced Formula; renu® Advanced Formula multi-purpose solution	Device: renu® Advanced Formula multi-purpose solution; renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall comfort averaged over all scheduled 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	3 months
Vision averaged over all scheduled follow-up visits	Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response	3 months
The proportion of eyes with a maximum degree of front surface deposits grade of < 2 over all scheduled follow-up visits	The degree of front surface deposits will be graded for each eye as 0, 1, 2, 3, or 4.	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.	3 months

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Daniel Donatello, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Pharmaceutical Solutions
• Other Study ID Numbers: 914 (Northumbria University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No