Contact LensesNCT03859440
Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses
A study testing DSiHy Silicone hydrogel soft contact lens and CE-marked Silicone hydrogel soft contact lens in people with Contact Lenses, run by HOYA Lamphun Ltd.
Trial summary
The purpose of this study is to evaluate the clinical performance of two daily disposable silicone hydrogel contact lenses. One of these lenses, the 'test' lens is an investigational product. This means that it has not yet been approved for commercial use and is not available for sale. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Contact Lenses
- What is being tested?
- DSiHy Silicone hydrogel soft contact lens and CE-marked Silicone hydrogel soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Oct 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be aged 20 years or more.
- Sign written informed consent.
- Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment).
- Contact lens sphere requirement between -1.00 to -6.00 D (inclusive).
- Refractive astigmatism (if present) less than or equal to 0.75 D in both eyes.
- Be correctable by sphero-cylindrical refraction to 6/7.5 (+0.10 logMAR 0.8 decimal) or better in each eye.
- Require visual correction in both eyes (monovision allowed, no monofit.
Who cannot join
- Require toric or multifocal contact lenses.
- Concurrent ocular medication.
- Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
- Any systemic illness affecting contact lens wear or the medical treatment of which would affect vision or successful lens wear (including diabetes).
- Clinically significant (≥Grade 2) corneal staining, corneal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- History of herpetic keratitis.
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- Pathological dry eye.
- Aphakia or amblyopia.
- History of refractive surgery, keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or within the last 30 days.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to evaluate the clinical performance of two daily disposable silicone hydrogel contact lenses. One of these lenses, the 'test' lens is an investigational product. This means that it has not yet been approved for commercial use and is not available for sale. The other lens (control) is a commercially available contact lens.
The results of this study will be analysed to determine how the 'test' lens compares with the 'control' lens. The control lens has been chosen because it is a market leader and is well tried and tested.
Participants who are in this study will need to have healthy eyes, except for the need to correct their eyesight. Up to 90 people who are aged 20 years or older will be considered for participation in this study. The study is designed to be approximately 3 months long.
- Conditions
- Contact Lenses
- Being tested
- DSiHy Silicone hydrogel soft contact lens, CE-marked Silicone hydrogel soft contact lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSiHy Silicone hydrogel soft contact lensDevice
•Device: DSiHy (test lens) Silicone hydrogel soft contact lens for daily disposable wear.
CE-marked Silicone hydrogel soft contact lensDevice
・Device: Silicone hydrogel soft contact lens CE-marked for daily disposable wear.
Other Name : MyDay
| Study group | Role | What they receive |
|---|---|---|
| DSiHy (test lens) | Experimental | Not described Receives: Device: DSiHy Silicone hydrogel soft contact lens |
| Silicone hydrogel soft contact lens CE-marked for daily use | Active comparator | Not described Receives: Device: CE-marked Silicone hydrogel soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens-related ocular adverse events requiring temporary or permanent discontinuation (resting eyes) as a proportion of follow-up eye examinations.
Measured: 13 week visit
Proportion of eyes with visual acuity corrected to 6/6 or better (1.0 decimal) at each visit.
Measured: 13 week visit
Proportion of eyes with best sphere-corrected visual acuity of 6/6 or better (1.0 decimal) at each visit.
Measured: 13 week visit
Secondary outcomes (6)
The following variables will be compared between lens types: Corneal staining - type (mean grade, 0-4)
Assessed by sector with fluorescein, blue light, yellow filter and full beam using medium magnification.
0 NONE: No staining
- Micropunctate - Punctate staining, minor localized or scattered in on one or two quadrants
- Macropunctate - Coalescent punctate staining, localized in one or two quadrants
- Widespread coalescent punctate staining in more than two quadrants
- Confluent staining or erosion (usually accompanied by hyperemia)
Measured: 13 week visit
The following variables will be compared between lens types: Limbal hyperemia (grade, 0-4)
Assessed using slit lamp with white light, low-medium magnification 0 NONE: No injection present
- TRACE: Slight limbal (mild segmented), bulbar (mild regional), and/or palpebral injection
- MILD: Mild limbal (mild circumcorneal), bulbar (mild diffuse) injection
- MODERATE: Significant limbal (marked segmented), bulbar (marked regional or diffuse) injection
- SEVERE: Severe limbal (marked circumcorneal), bulbar (diffuse episcleral or scleral) injection
Measured: 13 week visit
The following variables will be compared between lens types: Bulbar hyperemia (grade, 0-4).
Assessed using slit lamp with white light, low-medium magnification 0 NONE: No injection present
- TRACE: Slight limbal (mild segmented), bulbar (mild regional), and/or palpebral injection
- MILD: Mild limbal (mild circumcorneal), bulbar (mild diffuse) injection
- MODERATE: Significant limbal (marked segmented), bulbar (marked regional or diffuse) injection
- SEVERE: Severe limbal (marked circumcorneal), bulbar (diffuse episcleral or scleral) injection
Measured: 13 week visit
The following variables will be compared between lens types: Comfort (0-10)
Assessed by subject. 0 to 10 scale 10 = cannot be felt 0 = painful
Measured: 13 week visit
The following variables will be compared between lens types: Visual acuity (logMAR VA)
Measured: 13 week visit
The following variables will be compared between lens types: Wettability (0-4).
Lens surface wettability rated on the appearance of the lens surface and the drying time viewed with a slit lamp under low magnification.
0 VERY POOR: Immediately displaying non-wetting areas on lens surface.
- POOR: Irregular surface appearance; drying time <interblink period.
- ACCEPTABLE: Smooth surface appearance immediately after the blink becoming irregular with time; drying time >interblink period.
- GOOD: Typical lens appearance with long drying time.
- EXCELLENT: Appearance of a healthy cornea with very long drying time.
Measured: 13 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study startMay 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact LensesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HOYA Lamphun Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Graeme Young, Dr, Principal investigator, Visioncare Research Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859440
- Sponsor's protocol ID
- HOYA-3601
- Status last verified
- Mar 2019
- First submitted
- 20 Feb 2019
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-month Clinical Evaluation of DSiHy Daily Disposable Silicone Hydrogel Contact Lenses
- ClinicalTrials.gov ID
- NCT03859440
- Acronym / sponsor ID
- HOYA-3601
- Conditions
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- HOYA Lamphun LtdIndustry (pharma, biotech, devices)
- Study start
- May 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 1 Mar 2019 (actual)
- 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.
The purpose of this study is to evaluate the clinical performance of two daily disposable silicone hydrogel contact lenses. One of these lenses, the 'test' lens is an investigational product. This means that it has not yet been approved for commercial use and is not available for sale. The other lens (control) is a commercially available contact lens.
The results of this study will be analysed to determine how the 'test' lens compares with the 'control' lens. The control lens has been chosen because it is a market leader and is well tried and tested.
Participants who are in this study will need to have healthy eyes, except for the need to correct their eyesight. Up to 90 people who are aged 20 years or older will be considered for participation in this study. The study is designed to be approximately 3 months long.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSiHy (test lens) | Experimental | Device: DSiHy Silicone hydrogel soft contact lens |
| Silicone hydrogel soft contact lens CE-marked for daily use | Active comparator | Device: CE-marked Silicone hydrogel soft contact lens |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be aged 20 years or more.
- Sign written informed consent.
- Be a currently adapted soft contact lens wearer (i.e. be wearing lenses at least 1 month prior to enrolment).
- Contact lens sphere requirement between -1.00 to -6.00 D (inclusive).
- Refractive astigmatism (if present) less than or equal to 0.75 D in both eyes.
Key exclusion criteria (11 listed)
- Require toric or multifocal contact lenses.
- Concurrent ocular medication.
- Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
- Any systemic illness affecting contact lens wear or the medical treatment of which would affect vision or successful lens wear (including diabetes).
- Clinically significant (≥Grade 2) corneal staining, corneal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate 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 |
|---|---|---|
| DSiHy Silicone hydrogel soft contact lens•Device: DSiHy (test lens) Silicone hydrogel soft contact lens for daily disposable wear. | Device | DSiHy (test lens) |
| CE-marked Silicone hydrogel soft contact lens・Device: Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Other Name : MyDay | Device | Silicone hydrogel soft contact lens CE-marked for daily use |
Primary outcome
Lens-related ocular adverse events requiring temporary or permanent discontinuation (resting eyes) as a proportion of follow-up eye examinations.
Time frame: 13 week visit
Proportion of eyes with visual acuity corrected to 6/6 or better (1.0 decimal) at each visit.
Time frame: 13 week visit
Proportion of eyes with best sphere-corrected visual acuity of 6/6 or better (1.0 decimal) at each visit.
Time frame: 13 week visit
6 secondary outcomes
The following variables will be compared between lens types: Corneal staining - type (mean grade, 0-4)
Time frame: 13 week visit
The following variables will be compared between lens types: Limbal hyperemia (grade, 0-4)
Time frame: 13 week visit
The following variables will be compared between lens types: Bulbar hyperemia (grade, 0-4).
Time frame: 13 week visit
The following variables will be compared between lens types: Comfort (0-10)
Time frame: 13 week visit
The following variables will be compared between lens types: Visual acuity (logMAR VA)
Time frame: 13 week visit
The following variables will be compared between lens types: Wettability (0-4).
Time frame: 13 week visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Individual participant dataSharing planned: No
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Evaluation of Approved Contact Lenses (CR-6657)
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Using Contact Lenses and Spectacle Lenses as Myopia Interventions.
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Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
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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.
Graeme Young, Dr principal investigator
Visioncare Research Ltd.
Questions about this trial
What is this clinical trial studying?
A study testing DSiHy Silicone hydrogel soft contact lens and CE-marked Silicone hydrogel soft contact lens in people with Contact Lenses, run by HOYA Lamphun Ltd.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atsushi Uchida (+81 3 5913 2378, atsushi.uchida@hoya.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lens-related ocular adverse events requiring temporary or permanent discontinuation (resting eyes) as a proportion of follow-up eye examinations. (time frame: 13 week visit). The study lists 3 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 7 Mar 2019.