Refractive AmetropiaNCT05565937
A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution
A study testing BL-3100-NBR03 multi-purpose solution and renu® Advanced Formula multi-purpose solution in people with Refractive Ametropia, run by Bausch & Lomb Incorporated at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Ametropia
- What is being tested?
- BL-3100-NBR03 multi-purpose solution and renu® Advanced Formula multi-purpose solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 19 sitesUnited States
- Study dates
- 12 Apr 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
The Eyecare Studio, LLC
Decatur, Georgia, 30035
Chester T Roe III MD Prof LLC
Denver, Colorado, 80246
Biopharma Informatic
Houston, Texas, 77043
Spectrum Eyecare
Jamestown, New York, 14701
Complete Eye Care of Medina
Medina, Minnesota, 55340
Total Eye Care, PA
Memphis, Tennessee, 38119
Optometric Physicians of Middle Tennessee
Nashville, Tennessee, 37205
Eola Eyes
Orlando, Florida, 32803
Kannarr EyeCare
Pittsburg, Kansas, 66762
Casco Bay EyeCare
Portland, Maine, 04101
Oculus Research
Raleigh, North Carolina, 27603
Advanced Eye Care, PC
Raytown, Missouri, 64133
Eric White OD Inc
San Diego, California, 92123
Lee & Woo Optometry
San Francisco, California, 94112
Golden Vision
Sarasota, Florida, 34237
Koetting Associates
St Louis, Missouri, 63144
Saccco Eye Group
Vestal, New York, 13850
InSight Eyecare
Warrensburg, Missouri, 64093
Berlin Eyecare Associates
West Berlin, New Jersey, 08091
About this study
Official title: 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.
- Conditions
- Refractive Ametropia
- Being tested
- BL-3100-NBR03 multi-purpose solution, renu® Advanced Formula multi-purpose solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-3100-NBR03 multi-purpose solutionDevice
BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
renu® Advanced Formula multi-purpose solutionDevice
renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
| Study group | Role | What they receive |
|---|---|---|
| BL-3100-NBR03 | Experimental | BL-3100-NBR03 multi-purpose solution Receives: Device: BL-3100-NBR03 multi-purpose solution |
| renu® Advanced Formula | Active comparator | renu® Advanced Formula multi-purpose solution Receives: Device: renu® Advanced Formula multi-purpose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
- - 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.
Measured: 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.
Measured: Assessed at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start12 Apr 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractive AmetropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Donatello, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565937
- Sponsor's protocol ID
- 914
- Status last verified
- May 2025
- First submitted
- 30 Sep 2022
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution
- ClinicalTrials.gov ID
- NCT05565937
- Acronym / sponsor ID
- 914
- Conditions
- Refractive Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 4 Oct 2022 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-3100-NBR03 | Experimental | Device: BL-3100-NBR03 multi-purpose solutionBL-3100-NBR03 multi-purpose solution |
| renu® Advanced Formula | Active comparator | Device: renu® Advanced Formula multi-purpose solutionrenu® Advanced Formula multi-purpose solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (26 listed)
- 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:
- Has worn gas permeable (GP) lenses within the last 30 days
- Has worn polymethylmethacrylate (PMMA) lenses within the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-3100-NBR03 multi-purpose solutionBL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses | Device | BL-3100-NBR03 |
| renu® Advanced Formula multi-purpose solutionrenu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses | Device | renu® Advanced Formula |
Primary outcome
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
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
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. 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Donatello study director
Bausch & Lomb Incorporated
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BL-3100-NBR03 multi-purpose solution and renu® Advanced Formula multi-purpose solution in people with Refractive Ametropia, run by Bausch & Lomb Incorporated at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Comfort Averaged Over All Follow-up Visits (time frame: Assessed at all follow-up visits through 3 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.