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Pilot Dispensing Evaluation of a Plus Power Lens

Primary Purpose

Hyperopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acuvue Advance Plus
Acuvue Advance
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Acuvue Advance Plus/ Acuvue Advance

Acuvue Advance/Acuvue Advance Plus

Arm Description

Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.

Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 22, 2010
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01228591
Brief Title
Pilot Dispensing Evaluation of a Plus Power Lens
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acuvue Advance Plus/ Acuvue Advance
Arm Type
Other
Arm Description
Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
Arm Title
Acuvue Advance/Acuvue Advance Plus
Arm Type
Other
Arm Description
Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.
Intervention Type
Device
Intervention Name(s)
Acuvue Advance Plus
Intervention Description
Silicone hydrogel contact lens.
Intervention Type
Device
Intervention Name(s)
Acuvue Advance
Intervention Description
Silicone hydrogel contact lens
Primary Outcome Measure Information:
Title
Visual Acuity One Week After Lens Wear
Description
Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.
Time Frame
1 week
Title
Visual Acuity at Time of Initial Fit
Description
Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
Time Frame
After 10-15 minutes of lens wear
Secondary Outcome Measure Information:
Title
Contact Lens Comfort Using Contact Lens User Experience (CLUE)
Description
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.
Time Frame
1 week
Title
Subject Reported Vision Using Contact Lens User Experience (CLUE).
Description
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.
Time Frame
1 week
Title
Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)
Description
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.
Time Frame
Baseline
Title
Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Winter Park
State/Province
Florida
Country
United States
City
New York
State/Province
New York
Country
United States
City
Nanticoke
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Dispensing Evaluation of a Plus Power Lens

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