N/A
N=295
A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution
Refractive Ametropia
Bottom Line
View on ClinicalTrials.gov: NCT05565937 ↗Enrolled (actual)
295
Serious AEs
0.3%
Results posted
May 2025
Primary outcome: Primary: Overall Comfort Averaged Over All Follow-up Visits — 91.7; 90.7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BL-3100-NBR03 multi-purpose solution (Device); renu® Advanced Formula multi-purpose solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort Averaged Over All Follow-up Visits |
91.7; 90.7 | — |
| PRIMARY Vision Averaged Over All Follow-up Visits |
95.5; 94.3 | — |
| PRIMARY 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. |
99.3; 97.7; 0.7; 2.3 | — |
| PRIMARY The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits. |
0; 0.7; 100; 99.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05565937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.