Refractive ErrorNCT00639353
Silicone Hydrogel Contact Lenses on Low Astigmatism in Japan
A study testing senofilcon A toric soft contact lens and senofilcon A sphere soft contact lens in people with Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. at 10 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Refractive Error, Myopia, Astigmatism
- What is being tested?
- senofilcon A toric soft contact lens and senofilcon A sphere soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 10 sitesJapan
- Study dates
- Feb 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Shioya eye clinic
Fukushima, Fukushima
Kodama eye clinic
Jyoyoshi, Kyoto
Kajita eye clinic
Minatoku, Tokyo
Takahashi eye clinic
Odawarashi, Kanagawa
Inaba eye clinic
Osakashi, Osaka
Iwasaki eye clinic
Osakashi, Osaka
Watanabe eye clinic
Osakashi, Osaka
Dogenzakaitoi eye clinic
Shibuyaku, Tokyo
Ueda eye clinic
Shimonosekishi, Yamaguchi
Sakura eye clinic
Shizuoka, Shizuoka
About this study
Official title: The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan
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.
- Conditions
- Refractive Error, Myopia, Astigmatism
- Being tested
- senofilcon A toric soft contact lens, senofilcon A sphere soft contact lens
- Medical subject headings
- Refractive Errors, Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon A toric soft contact lensDevice
Also called ACUVUE OASYS for Astigmatism
contact lens
senofilcon A sphere soft contact lensDevice
Also called ACUVUE OASYS
contact lens
| Study group | Role | What they receive |
|---|---|---|
| spherical contact lens | Active comparator | Subjects will wear and evaluate a spherical soft contact lens daily for 2 weeks Receives: Device: senofilcon A sphere soft contact lens |
| toric contact lens | Experimental | Subjects will wear and evaluate a toric soft contact lens daily for 2 weeks Receives: Device: senofilcon A toric soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-reported satisfaction for vision
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Measured: After 2 weeks of lens wear
Subject-reported satisfaction for comfort.
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Measured: After 2 weeks of lens wear
Secondary outcomes (1)
Subject preference for lens type.
Measured: After 2 weeks of lens wear.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2008
Why it stopped: English to Japanese translation issues caused enrollment of incorrect and unqualified subjects; error applied to all subjects enrolled prior to termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639353
- Sponsor's protocol ID
- CR-0804
- Status last verified
- Oct 2014
- First submitted
- 14 Mar 2008
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan
- ClinicalTrials.gov ID
- NCT00639353
- Acronym / sponsor ID
- CR-0804
- Conditions
- Refractive Error, Myopia, Astigmatism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: English to Japanese translation issues caused enrollment of incorrect and unqualified subjects; error applied to all subjects enrolled prior to termination.
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- First posted
- 20 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spherical contact lens | Active comparator | Device: senofilcon A sphere soft contact lensSubjects will wear and evaluate a spherical soft contact lens daily for 2 weeks |
| toric contact lens | Experimental | Device: senofilcon A toric soft contact lensSubjects will wear and evaluate a toric soft contact lens daily for 2 weeks |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| senofilcon A toric soft contact lensAlso: ACUVUE OASYS for Astigmatismcontact lens | Device | toric contact lens |
| senofilcon A sphere soft contact lensAlso: ACUVUE OASYScontact lens | Device | spherical contact lens |
Primary outcome
Subject-reported satisfaction for vision
Time frame: After 2 weeks of lens wear
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Subject-reported satisfaction for comfort.
Time frame: After 2 weeks of lens wear
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
1 secondary outcome
Subject preference for lens type.
Time frame: After 2 weeks of lens wear.
Results and safety
The study was stopped early (reason given: English to Japanese translation issues caused enrollment of incorrect and unqualified subjects; error applied to all subjects enrolled prior to termination.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon A toric soft contact lens and senofilcon A sphere soft contact lens in people with Refractive Error and Myopia, run by Johnson & Johnson Vision Care, Inc. at 10 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: English to Japanese translation issues caused enrollment of incorrect and unqualified subjects; error applied to all subjects enrolled prior to termination.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject-reported satisfaction for vision (time frame: After 2 weeks of lens wear). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.