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

Study Overview
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Brief Summary
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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.

Official Title
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A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution

Conditions
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Refractive Ametropia

Intervention / Treatment
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* Device: BL-3100-NBR03 multi-purpose solution
* Device: renu® Advanced Formula multi-purpose solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BL-3100-NBR03<br>BL-3100-NBR03 multi-purpose solution | Device: BL-3100-NBR03 multi-purpose solution<br>* BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses<br>|
| Active Comparator: renu® Advanced Formula<br>renu® Advanced Formula multi-purpose solution | Device: renu® Advanced Formula multi-purpose solution<br>* renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall comfort averaged over all scheduled 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 | 3 months | 
| Vision averaged over all scheduled follow-up visits | Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response | 3 months | 
| The proportion of eyes with a maximum degree of front surface deposits grade of < 2 over all scheduled follow-up visits | The degree of front surface deposits will be graded for each eye as 0, 1, 2, 3, or 4. | 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. | 3 months |