7-Day, Multi-Site Study of an Investigational Multi-Purpose Disinfecting Solution for Contact Lens Wearers

Study Overview
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Brief Summary
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The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.

Official Title
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Corneal Staining Evaluation of SiH MPDS FID 114675A

Conditions
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Contact Lens Care

Intervention / Treatment
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* Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
* Device: Etafilcon A contact lens (ACUVUE® 2™)
* Device: Senofilcon A contact lens (ACUVUE® OASYS™)
* Device: Lotrafilcon B contact lens (O2 OPTIX®)
* 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. Wear contact lenses a minimum of 8 hours per day for at least 7-10 days prior to Visit 1 (screening visit). Vision correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses at Visit 1. Must discontinue contact lens wear for at least two consecutive days before Visit 2 (baseline visit). Other protocol-specified 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 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 114675A<br>FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only. | 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: Etafilcon A contact lens (ACUVUE® 2™)<br>* Commercially marketed hydrogel contact lens for daily wear use<br>* Other names: ACUVUE® 2™;Device: Senofilcon A contact lens (ACUVUE® OASYS™)<br>* Commercially marketed silicone hydrogel contact lens for daily wear use<br>* Other names: ACUVUE® OASYS™;Device: Lotrafilcon B contact lens (O2 OPTIX®)<br>* Commercially marketed silicone hydrogel contact lens for daily wear use<br>* Other names: O2 OPTIX®;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 |
| --- | --- | --- |
| 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. | Day 7 | 

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, Over the previous 2-3 hours, my lenses felt comfortable, with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree. | Day 7 | 

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