Pilot Dispensing Evaluation of a Plus Power Lens

Study Overview
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Brief Summary
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The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.

Conditions
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Hyperopia

Intervention / Treatment
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* Device: Acuvue Advance Plus
* Device: Acuvue Advance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must be at least 18 years of age and no more than 45 years of age. 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 (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study). The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D. 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, bifocal, in monovision contact lens wear, or is worn as extended wear. Need any near correction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Acuvue Advance Plus/ Acuvue Advance<br>Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second. | Device: Acuvue Advance Plus<br>* Silicone hydrogel contact lens.<br>Device: Acuvue Advance<br>* Silicone hydrogel contact lens<br>|
| Other: Acuvue Advance/Acuvue Advance Plus<br>Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second. | Device: Acuvue Advance Plus<br>* Silicone hydrogel contact lens.<br>Device: Acuvue Advance<br>* Silicone hydrogel contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity One Week After Lens Wear | Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected. | 1 week | 
| Visual Acuity at Time of Initial Fit | Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. | After 10-15 minutes of lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens Comfort Using Contact Lens User Experience (CLUE) | The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120. | 1 week | 
| Subject Reported Vision Using Contact Lens User Experience (CLUE). | Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120. | 1 week | 
| Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) | Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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. CLUE scores have a range of 0-120. | Baseline | 
| Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) | Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120. | Baseline |