Evaluation of an Investigational Multi-Purpose Solution (MPS)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.

Detailed Description
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A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.

Official Title
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Evaluation of an Investigational MPS

Conditions
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Study Focus is Healthy Contact Lens Wearers

Intervention / Treatment
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* Device: Investigational MPS
* Device: Opti-Free


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have successfully worn hydrogel contact lenses of the same material to be worn during the study Have normal eyes (with the exception of unaided visual acuity) Have successfully used a multi-purpose contact lens care solution Have acceptable visual acuity and lens wearing comfort at time of enrollment Exclusion Criteria: Concurrently enrolled another clinical trial Have a known sensitivity to any study product ingredient(s) Have a condition that may put them at significant risk

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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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: Investigational MPS<br>Investigational multipurpose disinfecting solution (study MPS) | Device: Investigational MPS<br>* Multi-purpose solution<br>* Other names: Cobra;|
| Active Comparator: Predicate MPS<br>Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS) | Device: Opti-Free<br>* Multi-purpose solution<br>* Other names: RepleniSH;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Lens Cleanliness as Measured by Light Reflectance | Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque). | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With no Corneal Staining | Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein. | Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adapted contact lens wearers