Back to resultsSilicone Hydrogel Contact Lenses on Low Astigmatism in Japan
Primary Purpose
Refractive Error, Myopia, Astigmatism
Status
Terminated
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
senofilcon A toric soft contact lens
senofilcon A sphere soft contact lens
Sponsored by
About this trial
This is an interventional treatment trial for Refractive Error
Eligibility Criteria
Inclusion Criteria:
- The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
- The subject has signed an informed consent with his/her own judgement for participation in the study.
- The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.
Exclusion Criteria:
- The subject has any ocular or systemic allergies that interfere with contact lens wear.
- The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
- The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.
- The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
- The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.
- The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.
- The subject has ocular infection.
- The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).
- The subject has corneal distortion resulting from previous experience of hard contact lens wear.
- The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.
- The subject has diabetes, as far as known to the subject.
- The subject is pregnant or in the lactation period, as far as known to the subject.
- The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses).
- The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study.
- The subject is a wearer of hard contact lenses (including rigid gas permeable).
- The subject is exposed to a dry environment on a constant basis.
- The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye.
- The subject is unable to follow the principal investigator's instructions.
- The subject is unable to follow lens hygiene procedures necessary for contact lens wear.
Sites / Locations
- Shioya eye clinic
- Takahashi eye clinic
- Kodama eye clinic
- Inaba eye clinic
- Iwasaki eye clinic
- Watanabe eye clinic
- Sakura eye clinic
- Kajita eye clinic
- Dogenzakaitoi eye clinic
- Ueda eye clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
spherical contact lens
toric contact lens
Arm Description
Subjects will wear and evaluate a spherical soft contact lens daily for 2 weeks
Subjects will wear and evaluate a toric soft contact lens daily for 2 weeks
Outcomes
Primary Outcome Measures
Subject-reported satisfaction for vision
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Subject-reported satisfaction for comfort.
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Secondary Outcome Measures
Subject preference for lens type.
Full Information
NCT ID
NCT00639353
First Posted
March 14, 2008
Last Updated
October 28, 2014
Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Johnson & Johnson
1. Study Identification
Unique Protocol Identification Number
NCT00639353
Brief Title
Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan
Official Title
The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
English to Japanese translation issues caused enrollment of incorrect and unqualified subjects; error applied to all subjects enrolled prior to termination.
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Johnson & Johnson
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error, Myopia, Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spherical contact lens
Arm Type
Active Comparator
Arm Description
Subjects will wear and evaluate a spherical soft contact lens daily for 2 weeks
Arm Title
toric contact lens
Arm Type
Experimental
Arm Description
Subjects will wear and evaluate a toric soft contact lens daily for 2 weeks
Intervention Type
Device
Intervention Name(s)
senofilcon A toric soft contact lens
Other Intervention Name(s)
ACUVUE OASYS for Astigmatism
Intervention Description
contact lens
Intervention Type
Device
Intervention Name(s)
senofilcon A sphere soft contact lens
Other Intervention Name(s)
ACUVUE OASYS
Intervention Description
contact lens
Primary Outcome Measure Information:
Title
Subject-reported satisfaction for vision
Description
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Time Frame
After 2 weeks of lens wear
Title
Subject-reported satisfaction for comfort.
Description
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Time Frame
After 2 weeks of lens wear
Secondary Outcome Measure Information:
Title
Subject preference for lens type.
Time Frame
After 2 weeks of lens wear.
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 is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
The subject has signed an informed consent with his/her own judgement for participation in the study.
The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.
Exclusion Criteria:
The subject has any ocular or systemic allergies that interfere with contact lens wear.
The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.
The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.
The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.
The subject has ocular infection.
The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).
The subject has corneal distortion resulting from previous experience of hard contact lens wear.
The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.
The subject has diabetes, as far as known to the subject.
The subject is pregnant or in the lactation period, as far as known to the subject.
The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses).
The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study.
The subject is a wearer of hard contact lenses (including rigid gas permeable).
The subject is exposed to a dry environment on a constant basis.
The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye.
The subject is unable to follow the principal investigator's instructions.
The subject is unable to follow lens hygiene procedures necessary for contact lens wear.
Facility Information:
Facility Name
Shioya eye clinic
City
Fukushimashi
State/Province
Fukushima
Country
Japan
Facility Name
Takahashi eye clinic
City
Odawarashi
State/Province
Kanagawa
Country
Japan
Facility Name
Kodama eye clinic
City
Jyoyoshi
State/Province
Kyoto
Country
Japan
Facility Name
Inaba eye clinic
City
Osakashi
State/Province
Osaka
Country
Japan
Facility Name
Iwasaki eye clinic
City
Osakashi
State/Province
Osaka
Country
Japan
Facility Name
Watanabe eye clinic
City
Osakashi
State/Province
Osaka
Country
Japan
Facility Name
Sakura eye clinic
City
Shizuokashi
State/Province
Shizuoka
Country
Japan
Facility Name
Kajita eye clinic
City
Minatoku
State/Province
Tokyo
Country
Japan
Facility Name
Dogenzakaitoi eye clinic
City
Shibuyaku
State/Province
Tokyo
Country
Japan
Facility Name
Ueda eye clinic
City
Shimonosekishi
State/Province
Yamaguchi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan
We'll reach out to this number within 24 hrs