Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
Primary Purpose
Refractive Error, Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Habitual Silicone Hydrogel Contact Lens
narafilcon A
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- They are of legal age (17 years) and capacity to volunteer.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
- They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
- They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
- They have successfully worn contact lenses within six months of starting the study.
Exclusion Criteria:
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
- They are pregnant or lactating.
- They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
- They have diabetes.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Sites / Locations
- Centre for Contact Lens Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Habitual silicone hydrogel
narafilcon A
Arm Description
Habitual contact lens wear.
Silicone hydrogel daily disposable contact lens
Outcomes
Primary Outcome Measures
Limbal Hyperemia
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Lens Comfort
Rating of lens comfort by rating agreement to the following statement:
"The lenses I am wearing are comfortable."
Rating using the following scale:
1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Upper Lid Margin Staining
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.
Secondary Outcome Measures
Tarsal Roughness
Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.
Tarsal Hyperemia
Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
Corneal Staining
A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.
Full Information
NCT ID
NCT00708643
First Posted
June 27, 2008
Last Updated
May 5, 2015
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT00708643
Brief Title
Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
University of Manchester
4. Oversight
5. Study Description
Brief Summary
This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Habitual silicone hydrogel
Arm Type
Active Comparator
Arm Description
Habitual contact lens wear.
Arm Title
narafilcon A
Arm Type
Experimental
Arm Description
Silicone hydrogel daily disposable contact lens
Intervention Type
Device
Intervention Name(s)
Habitual Silicone Hydrogel Contact Lens
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
narafilcon A
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Limbal Hyperemia
Description
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Time Frame
At 2 weeks and 4 weeks
Title
Lens Comfort
Description
Rating of lens comfort by rating agreement to the following statement:
"The lenses I am wearing are comfortable."
Rating using the following scale:
1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Time Frame
At 3,7,10,13,17,21,24, and 27 days
Title
Upper Lid Margin Staining
Description
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.
Time Frame
At 2 weeks and 4 weeks.
Secondary Outcome Measure Information:
Title
Tarsal Roughness
Description
Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.
Time Frame
At 2 weeks and 4 weeks
Title
Tarsal Hyperemia
Description
Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
Time Frame
At 2 weeks and 4 weeks.
Title
Corneal Staining
Description
A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.
Time Frame
At 2 weeks and 4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
They are of legal age (17 years) and capacity to volunteer.
They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
They have successfully worn contact lenses within six months of starting the study.
Exclusion Criteria:
They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They are aphakic.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
They are pregnant or lactating.
They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
They have diabetes.
They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Facility Information:
Facility Name
Centre for Contact Lens Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
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