Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.

Detailed Description
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Corneal staining and subjective responses for ocular redness and comfort will be compared.

Conditions
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Myopia

Intervention / Treatment
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* Device: Nelfilcon A contact lens
* Device: Etafilcon A contact lens
* Device: FID 107027 solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses. Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: History of hypersensitivity to any components of the multi-purpose solution. Evidence or history of ocular conditions as prescribed in protocol. One functional eye or a monofit lens Any slit-lamp finding score equal to 1 at Visit 1 of each study period. Significant corneal staining at visit 1 of each study period as prescribed in protocol. 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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nelfilcon A soak / Nelfilcon A no-soak<br>Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. | Device: Nelfilcon A contact lens<br>* Commercially marketed, single vision, soft contact lens for daily disposable wear<br>* Other names: Focus Dailies with AquaRelease;Device: FID 107027 solution<br>* Commercially marketed solution for contact lens disinfection<br>* Other names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution;|
| Active Comparator: Nelfilcon A no soak / nelfilcon A soak<br>Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. | Device: Nelfilcon A contact lens<br>* Commercially marketed, single vision, soft contact lens for daily disposable wear<br>* Other names: Focus Dailies with AquaRelease;Device: FID 107027 solution<br>* Commercially marketed solution for contact lens disinfection<br>* Other names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution;|
| Active Comparator: Etafilcon A soak / etafilcon A no soak<br>Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. | Device: Etafilcon A contact lens<br>* Commercially marketed, single vision, soft contact lens for daily disposable wear<br>* Other names: 1-Day ACUVUE Moist;Device: FID 107027 solution<br>* Commercially marketed solution for contact lens disinfection<br>* Other names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution;|
| Active Comparator: Etafilcon A no soak / etafilcon A soak<br>Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. | Device: Etafilcon A contact lens<br>* Commercially marketed, single vision, soft contact lens for daily disposable wear<br>* Other names: 1-Day ACUVUE Moist;Device: FID 107027 solution<br>* Commercially marketed solution for contact lens disinfection<br>* Other names: Opti-Free RepleniSH Multi-Purpose Disinfecting Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Corneal Staining Area | Percentage corneal staining was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together. | After 2 hours of wear | 
| Total Corneal Staining Type | Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0-none; 1-micropunctate; 2-macropunctate; 3-coalesced macropunctate; 4-patch (>/= 1mm). The five regions were summed. | After 2 hours of wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Comfort | Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes feel... with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable. | After 2 hours of wear | 
| Ocular Redness | Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, Right now my eyes look... with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red. | After two hours of wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Daily disposable contact lenses, Multi-purpose disinfecting solutions