A Safety and Effectiveness Study of BL-ABT12 Multi-Purpose Solution for Use by Participants With Soft Contact Lenses

Study Overview
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Brief Summary
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This study is to evaluate the safety and effectiveness of ABT12 Multi-Purpose solution (Test) compared to COMPLETE® Multi-Purpose Solution Easy Rub® Formula (COMPLETE Multi-Purpose Solution) when used by participants who are habitual contact lens wearers.

Detailed Description
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Eligible participants will be enrolled from 1 of 5 lens groups based on their habitual contact lenses. Participants will be randomized on a 1:1 basis within each group per site to receive either ABT12 Multi-Purpose solution or COMPLETE Multi-Purpose Solution. The 5 lens groups will be comprised of habitual wearers of soft lenses based on the following lens material: Etaficon A, Acuvue2, Vistakon Balafilcon A, PureVision2, Bausch + Lomb Samfilcon A, Ultra, Bausch + Lomb Lotrafilcon B, Optix Aqua, Alcon Senofilcon C, Vita, Vistakon

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

Conditions
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Contact Lens Wear

Intervention / Treatment
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* Device: ABT12 Multi-Purpose Solution
* Device: COMPLETE Multi-Purpose Solution
* Device: Sensitive Eyes® Rewetting Drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate local privacy regulations Is a habitual wearer (at least 3 months) of one of the following lens types: 1) Etaficon A, Acuvue2, Vistakon; 2) Balafilcon A, PureVision2, Bausch + Lomb; 3) Samfilcon A, Ultra, Bausch + Lomb; 4) Lotrafilcon B, Optix Aqua, Alcon; 5) Senofilcon C, Vita, Vistakon Vision is correctable through spherocylindrical refraction to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (distance, high contrast) in each eye with soft spherical contact lenses 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 3 months Is willing and able to comply with all treatment and follow-up/study procedures Exclusion Criteria: Participants who currently use a hydrogen-peroxide cleaning and disinfecting solution Participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation Females of childbearing potential (those who are not surgically sterilized or postmenopausal), if they are currently pregnant, plan to become pregnant during the study, or are breastfeeding Has worn gas permeable (GP) lenses within the last 30 days. Has worn polymethylmethacrylate (PMMA) lenses within the last 3 months 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 Has any ocular disease or is using any ocular medication Is using any systemic or topical 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 1.00 diopter (D) or greater in either eye Vision is not correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye with soft spherical contact lenses Has anisometropia (spherical equivalent) of greater than 2.00D Has any Grade 2 or greater finding during the slit lamp examination Has corneal infiltrates, of any grade Participants with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear Has any scar or neovascularization within the central 6 millimeters (mm) of the cornea. Note that participants with minor peripheral corneal scarring (that does not extend into the central area), that, in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study Is aphakic Is amblyopic Has had any corneal surgery (for example, 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 (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, or Johnson & Johnson) 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: ABT12 Multi-Purpose Solution<br>Participants will use ABT12 Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. | Device: ABT12 Multi-Purpose Solution<br>* Contact lens cleaning and disinfecting solution<br>Device: Sensitive Eyes® Rewetting Drops<br>* For use as needed during the study.<br>|
| Active Comparator: COMPLETE Multi-Purpose Solution<br>Participants will use COMPLETE Multi-Purpose Solution to clean their contact lenses daily for 3 months. Participants will use Sensitive Eyes Rewetting Drops as needed during the study. | Device: COMPLETE Multi-Purpose Solution<br>* Contact lens cleaning and disinfecting solution<br>* Other names: COMPLETE® Multi-Purpose Solution Easy Rub® Formula;Device: Sensitive Eyes® Rewetting Drops<br>* For use as needed during the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. | Month 3 | 
| Eye Dryness | Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. | Month 3 | 
| Degree Of Lens Deposits | Degree of lens deposits will be assessed for each eye as none, light, medium, or heavy. | Month 3 | 
| Proportion Of Participants With Eyes With Grade >2 Slit Lamp Findings | Graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Greater than Grade 2 findings (Absent, Present) will be summarized at the eye level by treatment. Grades are 0(none), 1 (Trace), 2 (Mild), 3 (moderate), 4 (severe) | Day 0 (post-dispensing) through Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lens Cleaning Solution, Disinfectants, Contact Lens, Soft Contact Lens