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

Completed · Not applicable

Conditions studied: Refractive Ametropia

In brief

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.

Key facts

Study ID

NCT05565937

Run by

Bausch & Lomb Incorporated

People needed

295

Starts

2023-04-12

Expected to finish

2024-02-28

Last updated by the study team

2025-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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