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

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Bausch + Lomb

Status

Completed

Conditions

Refractive Ametropia

Treatments

Device: renu® Advanced Formula multi-purpose solution
Device: BL-3100-NBR03 multi-purpose solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT05565937
914

Details and patient eligibility

About

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.

Enrollment

296 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

296 participants in 2 patient groups

BL-3100-NBR03
Experimental group
Description:
BL-3100-NBR03 multi-purpose solution
Treatment:
Device: BL-3100-NBR03 multi-purpose solution
renu® Advanced Formula
Active Comparator group
Description:
renu® Advanced Formula multi-purpose solution
Treatment:
Device: renu® Advanced Formula multi-purpose solution

Trial contacts and locations

0

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Central trial contact

Daniel Donatello

Data sourced from clinicaltrials.gov

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