A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens

Study Overview
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Brief Summary
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This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.

Official Title
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A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens

Conditions
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Contact Lens Wear

Intervention / Treatment
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* Device: Custom Samfilcon B Contact Lenses
* Device: Alden Optical HP Sphere Contact Lens
* Device: ReNu MultiPlus Lubricating and Rewetting Drops
* Device: Biotrue Multi-Purpose Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be 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 for local privacy regulations. Participants must have clear central corneas and be free of any anterior segment disorders in each eye. Participants must be myopic, require contact lens correction from -1.00 diopter (D) to -6.00 D, and wear contact lenses in each eye. Participants must be correctable through spherocylindrical refraction to 47 letters (0.0 logMAR) or better (distance, high-contrast) in each eye. Participants must be able and willing to comply with all treatment and follow-up/study procedures. Participants must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months. Exclusion Criteria: Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation. Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal), who are currently pregnant, plan to become pregnant during the study, or are breastfeeding. Participants who have worn gas permeable lenses in either eye within the last 30 days or who have worn polymethylmethacrylate lenses in either eye within the last 3 months. Participants with any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study. Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. Participants with an active ocular disease in either eye or who are using any ocular medication. Participants who currently wear monovision, multifocal, or toric contact lenses in either eye. Participants with an ocular astigmatism >1.00 D in either eye. Participants with anisometropia (spherical equivalent) >2.00 D. Participants with any Grade ≥2 finding in either eye during the slit lamp examination. Participants with corneal infiltrates in either eye, of any grade, are not eligible to participate in this study. Participants with any present finding during the slit lamp examination in either eye that, in the Investigator's judgment, interferes with contact lens wear. Participants with any scar or neovascularization within the central 6 millimeters (mm) of the cornea in either eye. Note: 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 to participate in this study. Participants who are aphakic in either eye. Participants who are amblyopic in either eye. Participants who have had any corneal surgery (for example, refractive surgery) in either eye. Participants who are allergic to any component in the study care products. Participants who meet any of the following criteria: The participant is an employee of the investigative site. The participant, or a member of the participant's household, is an ophthalmologist, an optometrist, an optician, or an ophthalmic assistant/technician. The participant, or a member of the participant's household, is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, or Johnson & Johnson). The participant, or a member of the participant's household, is an employee of a market research firm.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Custom Samfilcon B Contact Lenses<br>Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). | Device: Custom Samfilcon B Contact Lenses<br>* Contact lens<br>Device: ReNu MultiPlus Lubricating and Rewetting Drops<br>* For use as needed during the study.<br>* Other names: Bausch + Lomb ReNu MultiPlus® Lubricating and Rewetting Drops;Device: Biotrue Multi-Purpose Solution<br>* For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.<br>* Other names: Bausch + Lomb Biotrue® MPS;|
| Placebo Comparator: Alden Optical HP Sphere contact lenses<br>Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. | Device: Alden Optical HP Sphere Contact Lens<br>* Hioxifilcon D, 54% water, Alden Optical HP Sphere lens<br>* Other names: Alden Optical® HP Sphere lens;Device: ReNu MultiPlus Lubricating and Rewetting Drops<br>* For use as needed during the study.<br>* Other names: Bausch + Lomb ReNu MultiPlus® Lubricating and Rewetting Drops;Device: Biotrue Multi-Purpose Solution<br>* For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.<br>* Other names: Bausch + Lomb Biotrue® MPS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Distance High-contrast logMAR Lens VA | Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of All Study logMAR lens VA per eye. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion Of Eyes With Grade >2 Slit Lamp Findings | Graded slit lamp findings will be assessed at Month 3. Each eye will be classified with respect to having 1 or more observations with Grade >2 (Yes, No) at any visit. Criteria of each grade: 0=None, 1= Trace, 2= Mild, 3=Moderate, 4= Severe. Higher grades are worse outcomes. | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Soft Contact Lens, Soft Contact Lenses