AstigmatismNCT02801006
The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens
A study testing stenfilcon A and etafilcon A in people with Astigmatism, run by CooperVision, Inc. at 2 sites in Japan.
Trial summary
The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism
- What is being tested?
- stenfilcon A and etafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesJapan
- Study dates
- Apr 2016to 31 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is between 18 years of age and 42 years of age.
- Soft contact lens wearers who are not required to have Presbyopic correction.
- Soft contact lens wearers without trouble.
- Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
- Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
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- Can achieve a corrected visual acuity of 1.0 or better.
- Can read and understand the study information document, and sign the participation consent form.
- Can visit the clinic at designated examination visits.
- Has received periodical examinations at an eye clinic within the past two years.
Who cannot join
- A person will be excluded from the study if he/she:
- Has a systemic disease that may affect the ocular health.
- Is pregnant or lactating.
- Has received a systemic or local medication that may affect this study.
- Has an infectious eye disease.
- Has eye and systemic active allergic diseases that interferes with SCL wear.
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- Has an eye disease which is clinically judged to be severe such as corneal vascularization, limbal hyperemia, and corneal epithelium disorder
- Has a history of hard contact lens wear within 30 days.
- Is currently participating in another clinical research study.
- Has undergone refractive surgery.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Dougenzaka Ioti Eye Clinic
Shibuya City, Tokyo-to, 150-0043
Kodama Eye Clinic
Terada, Kyoto, 610-0121
About this study
The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.
Read the detailed description
This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.
- Conditions
- Astigmatism
- Being tested
- stenfilcon A, etafilcon A
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stenfilcon ADevice
contact lens
etafilcon ADevice
contact lens
| Study group | Role | What they receive |
|---|---|---|
| stenfilcon A | Experimental | Participants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study. Receives: Device: stenfilcon A |
| etafilcon A | Active comparator | Participants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study. Receives: Device: etafilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort
Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all
Measured: 2 weeks
Dryness
Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all
Measured: 2 weeks
Clarity of Vision
Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all
Measured: 2 weeks
Stability of Vision
Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision
Measured: 2 weeks
Lens Handling
Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all
Measured: 2 weeks
Overall Satisfaction
Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AstigmatismStudies 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
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuji Kodama, MD, PhD, Principal investigator, Director, Kodama Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801006
- Sponsor's protocol ID
- JP-MKTG-201603
- Status last verified
- Dec 2017
- First submitted
- 10 Jun 2016
- Last updated
- 9 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Silicone Hydrogel Daily Disposable Stenfilcon A Toric Lens
- ClinicalTrials.gov ID
- NCT02801006
- Acronym / sponsor ID
- JP-MKTG-201603
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Posted 12 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the clinical performance of stenfilcon A toric lenses compared with etafilcon A toric lenses for astigmatism. If it is valuable, the clinical performance of stenfilcon A toric lens is also evaluated compared with habitual lenses.
Detailed description
This is a multi-sites, 50 subjects, randomized, open labeled, bilateral wear, dispensing study. Participants will be randomized to wear first lens pair for two weeks, and then crossover to second lens pair for two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stenfilcon A | Experimental | Device: stenfilcon AParticipants will be randomized to wear stenfilcon A lens pair for two weeks during the cross over study. |
| etafilcon A | Active comparator | Device: etafilcon AParticipants will be randomized to wear etafilcon A lens pair for two weeks during the cross over study. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Is between 18 years of age and 42 years of age.
- Soft contact lens wearers who are not required to have Presbyopic correction.
- Soft contact lens wearers without trouble.
- Soft contact lens wearers who have the correctable astigmatism by lenses used in this study in the both eyes.
- Has a prescribed SCL (Soft Contact Lens) power within the range of powers of the SCL for astigmatism which is used in this study.
Key exclusion criteria (10 listed)
- Has a systemic disease that may affect the ocular health.
- Is pregnant or lactating.
- Has received a systemic or local medication that may affect this study.
- Has an infectious eye disease.
- Has eye and systemic active allergic diseases that interferes with SCL 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 |
|---|---|---|
| stenfilcon Acontact lens | Device | stenfilcon A |
| etafilcon Acontact lens | Device | etafilcon A |
Primary outcome
Comfort
Time frame: 2 weeks
Wearing comfort (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0= extremely uncomfortable cannot wear at all, 10=very comfortable and feel no lens at all
Dryness
Time frame: 2 weeks
Dryness (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=extremely dried and cannot wear lens, 10=feel no dryness at all
Clarity of Vision
Time frame: 2 weeks
Clarity of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=blur vision and cannot see at all, 10=very clear with no blur vision at all
Stability of Vision
Time frame: 2 weeks
Stability of vision (throughout the day) for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=unstable vision and cannot see at all, 10=always stable vision
Lens Handling
Time frame: 2 weeks
Lens handling for stenfilcon A and etafilcon A toric lens pair is assessed. Scale 0-10, 0=cannot handle at all, 10=no problem at all
Overall Satisfaction
Time frame: 2 weeks
Overall satisfaction for stenfilcon A and etafilcon A toric lens pair is assessed. scale 0-10, 0=extremely un-satisfy, 10=very satisfy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Yuji Kodama, MD, PhD principal investigator
Director, Kodama Eye Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stenfilcon A and etafilcon A in people with Astigmatism, run by CooperVision, Inc. at 2 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comfort (time frame: 2 weeks). The study lists 6 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 9 Jan 2018.