A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution
NCT ID: NCT05565937
Last Updated: 2025-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
295 participants
INTERVENTIONAL
2023-04-12
2024-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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BL-3100-NBR03
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
renu® Advanced Formula
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
Interventions
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BL-3100-NBR03 multi-purpose solution
BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
renu® Advanced Formula multi-purpose solution
renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Donatello
Role: STUDY_DIRECTOR
Bausch & Lomb Incorporated
Locations
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Eric White OD Inc
San Diego, California, United States
Lee & Woo Optometry
San Francisco, California, United States
Chester T Roe III MD Prof LLC
Denver, Colorado, United States
Eola Eyes
Orlando, Florida, United States
Golden Vision
Sarasota, Florida, United States
The Eyecare Studio, LLC
Decatur, Georgia, United States
Kannarr EyeCare
Pittsburg, Kansas, United States
Casco Bay EyeCare
Portland, Maine, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Advanced Eye Care, PC
Raytown, Missouri, United States
Koetting Associates
St Louis, Missouri, United States
InSight Eyecare
Warrensburg, Missouri, United States
Berlin Eyecare Associates
West Berlin, New Jersey, United States
Spectrum Eyecare
Jamestown, New York, United States
Saccco Eye Group
Vestal, New York, United States
Oculus Research
Raleigh, North Carolina, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Optometric Physicians of Middle Tennessee
Nashville, Tennessee, United States
Biopharma Informatic
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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914
Identifier Type: -
Identifier Source: org_study_id
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