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Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Etafilcon A toric contact lens
Nelfilcon A toric contact 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 Astigmatism

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The subject must be between 18 and 40 years old.
  • The subject must have normal eyes.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
  • The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.
  • The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
  • The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.
  • The subject must be an adapted wearer of soft toric contact lenses in both eyes.
  • The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
  • Subjects must already possess a wearable pair of spectacles.

Exclusion Criteria:

  • Ocular or systemic allergies or disease that may interfere with contact lens wear.
  • Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities that 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
  • Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • Diabetes
  • Strabismus

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Etafilcon A toric contact lens/Nelfilcon A toric

Nelfilcon A toric/ Etafilcon A toric

Arm Description

Etafilcon A toric contact lens first, then nelfilcon A toric second

Nelfilcon A toric contact lens first, then etafilcon A toric toric second

Outcomes

Primary Outcome Measures

Monocular Visual Acuity on LogMAR Scale
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Binocular Visual Acuity on LogMAR Scale
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
The Contact Lens User Evaluation(CLUE)TM questionnaire 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 Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
The Contact Lens User Evaluation(CLUE)TM questionnaire 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).

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT01055132
Brief Title
Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
Official Title
Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 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 determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Etafilcon A toric contact lens/Nelfilcon A toric
Arm Type
Other
Arm Description
Etafilcon A toric contact lens first, then nelfilcon A toric second
Arm Title
Nelfilcon A toric/ Etafilcon A toric
Arm Type
Other
Arm Description
Nelfilcon A toric contact lens first, then etafilcon A toric toric second
Intervention Type
Device
Intervention Name(s)
Etafilcon A toric contact lens
Intervention Description
contact lens to correct astigmatism
Intervention Type
Device
Intervention Name(s)
Nelfilcon A toric contact lens
Intervention Description
contact lens to correct astigmatism
Primary Outcome Measure Information:
Title
Monocular Visual Acuity on LogMAR Scale
Description
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Time Frame
After 5 to 9 days of lens wear
Title
Binocular Visual Acuity on LogMAR Scale
Description
Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Time Frame
After 5 to 9 days of lens wear
Title
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
Description
The Contact Lens User Evaluation(CLUE)TM questionnaire 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
After 5 to 9 days of lens wear
Title
Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
Description
The Contact Lens User Evaluation(CLUE)TM questionnaire 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
After 5 to 9 days of lens wear

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must be between 18 and 40 years old. The subject must have normal eyes. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye. The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye. The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye. The subject must be an adapted wearer of soft toric contact lenses in both eyes. The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye. Subjects must already possess a wearable pair of spectacles. Exclusion Criteria: Ocular or systemic allergies or disease that may interfere with contact lens wear. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear. Clinically significant (grade 3 or 4) tarsal abnormalities that 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 Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). Diabetes Strabismus
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90049
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

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