Pilot Dispensing Evaluation of a Plus Power Lens
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 38
- Locations
- 3
- Primary Endpoint
- Visual Acuity One Week After Lens Wear
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Acuvue Advance Plus/ Acuvue Advance
Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
Intervention: Acuvue Advance Plus (Device)
Acuvue Advance Plus/ Acuvue Advance
Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
Intervention: Acuvue Advance (Device)
Acuvue Advance/Acuvue Advance Plus
Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.
Intervention: Acuvue Advance Plus (Device)
Acuvue Advance/Acuvue Advance Plus
Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.
Intervention: Acuvue Advance (Device)
Outcomes
Primary Outcomes
Visual Acuity One Week After Lens Wear
Time Frame: 1 week
Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.
Visual Acuity at Time of Initial Fit
Time Frame: After 10-15 minutes of lens wear
Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
Secondary Outcomes
- Contact Lens Comfort Using Contact Lens User Experience (CLUE)(1 week)
- Subject Reported Vision Using Contact Lens User Experience (CLUE).(1 week)
- Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)(Baseline)
- Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)(Baseline)