Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

Study Overview
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Brief Summary
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The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Conditions
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Myopia

Intervention / Treatment
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* Device: galyfilcon A prototype lens
* Device: comfilcon A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D. Any cylinder power must be ≤ -0.75D. The subject must have visual acuity best correctable to 20/25+3 or better for each eye. The subject must read and sign the Statement of Informed Consent. The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol. Exclusion Criteria: Ocular or systemic allergies or disease which might interfere with contact lens wear. Systemic disease or use of medication which might interfere with contact lens wear. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. Any ocular infection. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. Pregnancy or lactation. Diabetes. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: galyfilcon A prototype/comfilcon A<br>The galyfilcon A prototype lenses are worn during first period and comfilcon A lenses worn during second period. Each period consists of daily lens wear for one week. | Device: galyfilcon A prototype lens<br>* silicone hydrogel contact lens<br>Device: comfilcon A<br>* silicone hydrogel contact lens<br>* Other names: Biofinity® contact lens;|
| Other: comfilcon A/galyfilcon A prototype<br>The comfilcon A lenses are worn during first period and galyfilcon A prototype lenses worn during second period. Each period consists of daily lens wear for one week. | Device: galyfilcon A prototype lens<br>* silicone hydrogel contact lens<br>Device: comfilcon A<br>* silicone hydrogel contact lens<br>* Other names: Biofinity® contact lens;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity Monocular | Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens. | after 7 +/- 1 days of lens wear | 
| Visual Acuity Binocular | Snellen binocular visual acuity measurement | after 7 +/- 1 days of lens wear | 
| Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. | after 7 +/-1 days of lens wear | 
| Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. | Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. | after 7 +/- 1 days of lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limbal Redness | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. | after 7 days of lens wear | 
| Bulbar Redness | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. | after 7 days of lens wear | 
| Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. | 10 minutes after lens insertion at time of initial lens fitting |