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OpenTrials
Completed

NCT Number: NCT05565937

A Study to Evaluate the Safety and Effectiveness 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eric White OD Inc, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Has any grade 2 or greater finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation)
  • Has corneal infiltrates, of ANY GRADE
  • 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.
  • 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.
  • Is aphakic
  • Is amblyopic
  • Has had any corneal surgery (e.g., refractive surgery)
  • Is allergic to any component in the study care products.
  • 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
  • Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties
  • 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.

Treatment and study plan

BL-3100-NBR03 multi-purpose solution

Device

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

renu® Advanced Formula multi-purpose solution

Device

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

Primary outcomes

  1. Overall Comfort Averaged Over All Follow-up Visits

    Time frame: Assessed at all follow-up visits through 3 months.

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

  2. Vision Averaged Over All Follow-up Visits

    Time frame: Assessed at all follow-up visits through 3 months.

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

  3. 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.

    Time frame: Assessed at all follow-up visits through 3 months.

    The degree of front surface deposits will be graded for each eye as:

    0 - Absent, clean surface.

    • - Very slight, only visible after tear film drying.
    • - Slight, visible deposits easily removable.
    • - Moderate, deposits adherent and not removable.
    • - Severe, non-removable deposits and comfort affected.
  4. The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.

    Time frame: Assessed at 3 months

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

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2022
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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