search
Back to results

Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
galyfilcon A prototype lens
marketed galyfilcon A lens
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject must be at least 18 years of age and no more than 39 years of age.
  • The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
  • The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
  • 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 this 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, multifocal, or is worn as extended wear.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

galyfilcon A prototype/marketed galyfilcon A

marketed galyfilcon A/galyfilcon A prototype

Arm Description

The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.

The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.

Outcomes

Primary Outcome Measures

Lens Front Surface Deposits at Day 7
Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.
Lens Front Surface Deposits at Day 14
Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.

Secondary Outcome Measures

Subject Reported Overall Lens Comfort at Day 7
The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Subject Reported Overall Lens Comfort at Day 14
The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).

Full Information

First Posted
March 24, 2010
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01094730
Brief Title
Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens
Official Title
A Multi-site Dispensing Evaluation Comparing a New Galyfilcon A Prototype Lens With a Marketed Galyfilcon A Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2010 (Actual)
Primary Completion Date
April 1, 2010 (Actual)
Study Completion Date
April 1, 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 lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
galyfilcon A prototype/marketed galyfilcon A
Arm Type
Other
Arm Description
The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.
Arm Title
marketed galyfilcon A/galyfilcon A prototype
Arm Type
Other
Arm Description
The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.
Intervention Type
Device
Intervention Name(s)
galyfilcon A prototype lens
Intervention Description
Experimental silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
marketed galyfilcon A lens
Other Intervention Name(s)
ACUVUE(R) ADVANCE(TM)
Intervention Description
Marketed silicone hydrogel contact lens.
Primary Outcome Measure Information:
Title
Lens Front Surface Deposits at Day 7
Description
Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.
Time Frame
Evaluated at Day 7
Title
Lens Front Surface Deposits at Day 14
Description
Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.
Time Frame
Evaluated at Day 14
Secondary Outcome Measure Information:
Title
Subject Reported Overall Lens Comfort at Day 7
Description
The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Time Frame
Evaluated at Day 7
Title
Subject Reported Overall Lens Comfort at Day 14
Description
The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging)in a contact lens wearing population 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. 97% of the scores fall within 0 and 120 (mean +/-3*SD).
Time Frame
Evaluated at Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must be at least 18 years of age and no more than 39 years of age. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D. 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 this 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, multifocal, or is worn as extended wear.
Facility Information:
City
Cupertino
State/Province
California
Country
United States
City
Huntington Beach
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Pismo Beach
State/Province
California
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
East Lansing
State/Province
Michigan
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Amarillo
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens

We'll reach out to this number within 24 hrs