Back to resultsClinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Primary Purpose
Refractive Error, Myopia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
spectacles
narafilcon A soft contact lenses
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- They are of legal age (18 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
- Eurolens Research, The University of Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
spectacles
narafilcon A soft contact lenses
Arm Description
habitual spectacles worn daily for 12 months
narafilcon A soft contact lenses worn as daily disposable for 12 months
Outcomes
Primary Outcome Measures
Papillary Conjunctivitis
Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.
Secondary Outcome Measures
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.
Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.
Visual Acuity After 12 Months of Wear
Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.
Subjective Overall Comfort After 12 Months of Daily Wear
subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort
Subjective Overall Vision After 12 Months of Daily Wear
subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision
Full Information
NCT ID
NCT00708032
First Posted
June 27, 2008
Last Updated
December 3, 2019
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT00708032
Brief Title
Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Official Title
Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2008 (Actual)
Primary Completion Date
December 1, 2009 (Actual)
Study Completion Date
December 1, 2009 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.
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
Participant
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spectacles
Arm Type
Other
Arm Description
habitual spectacles worn daily for 12 months
Arm Title
narafilcon A soft contact lenses
Arm Type
Experimental
Arm Description
narafilcon A soft contact lenses worn as daily disposable for 12 months
Intervention Type
Device
Intervention Name(s)
spectacles
Intervention Description
habitual spectacles
Intervention Type
Device
Intervention Name(s)
narafilcon A soft contact lenses
Intervention Description
narafilcon A daily disposable contact lenses
Primary Outcome Measure Information:
Title
Papillary Conjunctivitis
Description
Papillary conjunctivitis which is collected as part of the biomicroscopy data and is identified from a slit lamp examination. Grade 0 to Grade 4 with grade 0 implying no health concerns.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis.
Description
Comprised of 8 categories (conjunctival hyperemia, limbal hyperemia, corneal vascularization, microcysts, Oedema, corneal staining, conjunctival staining and papillary conjunctivitis) each scored on a scale of 0 to 4 where 0=none, and 4=maximum score for each category.
Time Frame
at 12 months
Title
Visual Acuity After 12 Months of Wear
Description
Visual acuity is measured at high and low contrasts, via the Snellen scale which is then mathematically converted to logMar units. High contrast refers to a darker print on the Snellen chart and is an easier testing environment compared to the low contrast which has a grayer print.
Time Frame
at 12 months
Title
Subjective Overall Comfort After 12 Months of Daily Wear
Description
subject response using a scale of 0 to 100, where 0 = poor comfort, 100 = excellent comfort
Time Frame
at 12 months
Title
Subjective Overall Vision After 12 Months of Daily Wear
Description
subject response using a scale of 0 to 100, where 0 = poor vision, 100 = excellent vision
Time Frame
at 12 months
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:
They are of legal age (18 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
Eurolens Research, The University of Manchester
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M60 1QD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
We'll reach out to this number within 24 hrs