Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution

Study Overview
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Brief Summary
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The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.

Official Title
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Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution

Conditions
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Contact Lens Care

Intervention / Treatment
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* Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
* Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)
* Device: Senofilcon A contact lens (ACUVUE® Oasys™)
* Device: Balafilcon A contact lens (PureVision®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening). Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening). Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline). Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study. Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products). Monocular vision (only one eye with functional vision) or fit with only one contact lens. Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit. Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator. Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months. Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits. Corneal staining area assessment ≥ 20% in any corneal region in either eye at screening or baseline visit. Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit. Participation in any investigational clinical study within 30 days of baseline visit. Other protocol-defined 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: FID 114675A / RepleniSH<br>FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis. | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)<br>* Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.<br>Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)<br>* Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.<br>* Other names: (OPTI-FREE® RepleniSH®);Device: Senofilcon A contact lens (ACUVUE® Oasys™)<br>* Commercially marketed silicone hydrogel contact lens for daily wear use<br>* Other names: ACUVUE® Oasys™;Device: Balafilcon A contact lens (PureVision®)<br>* Commercially marketed silicone hydrogel contact lens for daily wear use<br>* Other names: PureVision®;|
| Other: RepleniSH / FID 114675A<br>RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis. | Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)<br>* Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.<br>Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)<br>* Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.<br>* Other names: (OPTI-FREE® RepleniSH®);Device: Senofilcon A contact lens (ACUVUE® Oasys™)<br>* Commercially marketed silicone hydrogel contact lens for daily wear use<br>* Other names: ACUVUE® Oasys™;Device: Balafilcon A contact lens (PureVision®)<br>* Commercially marketed silicone hydrogel contact lens for daily wear use<br>* Other names: PureVision®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ex-Vivo Wetting Angle | Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens. | Day 7, Hour 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Lens Comfort | Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, My lenses feel comfortable right now, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree. | Day 7, Hour 14 | 
| Percentage of Participants With Solution-Related Corneal Staining | Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants. | Day 7, Hour 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lenses, Disinfecting solutions