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Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
galyfilcon A prototype lens
lotrafilcon B 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:

  1. The subject must be at least 18 years of age and no more than 39 years of age.
  2. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of 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.
  3. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
  4. Any cylinder power must be ≤ -0.75D.
  5. The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
  6. The subject must read and sign the Statement of Informed Consent.
  7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

  1. Ocular or systemic allergies or disease which might interfere with contact lens wear.
  2. Systemic disease or use of medication which might interfere with contact lens wear.
  3. 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.
  4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  5. Any ocular infection.
  6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  7. Pregnancy or lactation.
  8. Diabetes.
  9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  10. 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 lens / lotrafilcon B lens

lotrafilcon B lens / galyfilcon A prototype lens

Arm Description

The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.

The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.

Outcomes

Primary Outcome Measures

Visual Acuity Monocular
Snellen monocular visual acuity measurement
Visual Acuity Binocular
Snellen binocular visual acuity measurement
Subjective Assessment of Lens Comfort
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Subjective Assessment of Quality of Vision
Contact Lens User Experience (CLUE)TM questionnaire: 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.

Secondary Outcome Measures

Limbal Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Bulbar Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Subjective Assessment of Lens Comfort
Contact Lens User Experience (CLUE)TM questionnaire: 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.

Full Information

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

Unique Protocol Identification Number
NCT01094743
Brief Title
Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2010 (Actual)
Primary Completion Date
March 1, 2010 (Actual)
Study Completion Date
March 1, 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already 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
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
galyfilcon A prototype lens / lotrafilcon B lens
Arm Type
Other
Arm Description
The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.
Arm Title
lotrafilcon B lens / galyfilcon A prototype lens
Arm Type
Other
Arm Description
The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.
Intervention Type
Device
Intervention Name(s)
galyfilcon A prototype lens
Intervention Description
Silicone hydrogel contact lens
Intervention Type
Device
Intervention Name(s)
lotrafilcon B lens
Intervention Description
Silicon Hydrogel contact lens
Primary Outcome Measure Information:
Title
Visual Acuity Monocular
Description
Snellen monocular visual acuity measurement
Time Frame
after 1 week of lens wear
Title
Visual Acuity Binocular
Description
Snellen binocular visual acuity measurement
Time Frame
after 1 week of lens wear
Title
Subjective Assessment of Lens Comfort
Description
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Time Frame
after 1 week of lens wear
Title
Subjective Assessment of Quality of Vision
Description
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Time Frame
after 1 week of lens wear
Secondary Outcome Measure Information:
Title
Limbal Redness
Description
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time Frame
after 1 week of lens wear
Title
Bulbar Redness
Description
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time Frame
after 1 week of lens wear
Title
Subjective Assessment of Lens Comfort
Description
Contact Lens User Experience (CLUE)TM questionnaire: 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.
Time Frame
10 minutes after lens insertion at time of initial lens fitting

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 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
Jacksonville
State/Province
Florida
Country
United States
City
Salem
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens

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