Clear Care® Plus vs. PeroxiClear™

Study Overview
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Brief Summary
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The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.

Detailed Description
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Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.

Official Title
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Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers

Conditions
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Refractive Error

Intervention / Treatment
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* Device: Clear Care Plus contact lens solution
* Device: PeroxiClear contact lens solution
* Device: Silicone hydrogel contact lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign informed consent form; Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months); Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits; Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Current hydrogen peroxide-based solution user; Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment; Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day; Use of systemic or ocular medications for which contact lens wear could be contraindicated; Monocular (only 1 eye with functional vision) or fit with only 1 lens; History of herpetic keratitis, ocular surgery, or irregular cornea; Other protocol-specified exclusion criteria may apply.

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clear Care Plus, then PeroxiClear<br>Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. | Device: Clear Care Plus contact lens solution<br>* 3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses<br>* Other names: Clear Care Plus;Device: PeroxiClear contact lens solution<br>* 3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses<br>* Other names: PeroxiClear;Device: Silicone hydrogel contact lenses<br>* 2-week/monthly replacement contact lenses per participant's habitual brand<br>|
| Other: PeroxiClear, then Clear Care Plus<br>PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles. | Device: Clear Care Plus contact lens solution<br>* 3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses<br>* Other names: Clear Care Plus;Device: PeroxiClear contact lens solution<br>* 3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses<br>* Other names: PeroxiClear;Device: Silicone hydrogel contact lenses<br>* 2-week/monthly replacement contact lenses per participant's habitual brand<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Residual Peroxide at Day 30 | The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear). | Day 30, each product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Osmolality in Lens Cases at Day 30 | The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear). | Day 30, each product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens solution