Pilot Dispensing Evaluation of a Plus Power Lens

Not Applicable

Completed

• Conditions: Hyperopia
• Interventions: Device: Acuvue Advance Plus; Device: Acuvue Advance

• Registration Number: NCT01228591
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-22
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2013-09-17
• Results First Submitted QC: 2013-12-16
• Results First Posted: 2014-02-03
• Status Verified: 2015-05
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acuvue Advance Plus/ Acuvue Advance	Acuvue Advance	Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
Acuvue Advance Plus/ Acuvue Advance	Acuvue Advance Plus	Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
Acuvue Advance/Acuvue Advance Plus	Acuvue Advance Plus	Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.
Acuvue Advance/Acuvue Advance Plus	Acuvue Advance	Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.

Primary Outcome Measures

Name	Time	Method
Visual Acuity One Week After Lens Wear	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	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 Outcome Measures

Name	Time	Method
Contact Lens Comfort Using Contact Lens User Experience (CLUE)	1 week	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.
Subject Reported Vision Using Contact Lens User Experience (CLUE).	1 week	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.
Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)	Baseline	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.
Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)	Baseline	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.