Pilot Dispensing Evaluation of a Plus Power Lens

• ClinicalTrials.gov Identifier: NCT01228591
• Recruitment Status: Completed
• First Posted: October 26, 2010
• Results First Posted: February 3, 2014
• Last Update Posted: June 19, 2018
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hyperopia	Device: Acuvue Advance Plus; Device: Acuvue Advance	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: October 2010
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

Arm	Intervention/treatment
Acuvue Advance Plus/ Acuvue Advance; Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.	Device: Acuvue Advance Plus; Silicone hydrogel contact lens.; Device: Acuvue Advance; Silicone hydrogel contact lens
Acuvue Advance/Acuvue Advance Plus; Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.	Device: Acuvue Advance Plus; Silicone hydrogel contact lens.; Device: Acuvue Advance; Silicone hydrogel contact lens

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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 Outcome Measures :

1. Contact Lens Comfort Using Contact Lens User Experience (CLUE) [ Time Frame: 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.
2. Subject Reported Vision Using Contact Lens User Experience (CLUE). [ Time Frame: 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.
3. Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) [ Time Frame: 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.
4. Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Winter Park, Florida, United States

United States, New York

New York, New York, United States

United States, Pennsylvania

Nanticoke, Pennsylvania, United States

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT01228591
• Other Study ID Numbers: CR-1636BB
• First Posted: October 26, 2010
• Results First Posted: February 3, 2014
• Last Update Posted: June 19, 2018
• Last Verified: May 2015

Additional relevant MeSH terms:

Hyperopia; Refractive Errors; Eye Diseases