MyopiaNCT02676258
Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens
A study testing Si-Hy (olifilcon B) and Vistakon (narafilcon A) in people with Myopia, run by Visco Vision Inc. at 1 site in Taiwan.
Trial summary
The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Si-Hy (olifilcon B) and Vistakon (narafilcon A)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2015to Nov 2015
- 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
- Subject should have normal eyes and use no ocular medications
- Subject with -1.00 to -10.00 D myopia, less than 2.00 D astigmatism
- VA correctable to Log MAR 0.1 or better.
- Willing to comply with all study procedures and be available for the duration of the study.
- Provide signed and dated informed consent form.
Who cannot join
- Subjects have history of allergies that would contraindicate "normal" contact lens wear.
- Subjects have other active ocular or systemic disease such as, but not limited to : anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes.
- Subjects have medications that would contraindicate contact lens wear.
- Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Any active participation in another clinical trial within 30 days prior to this study.
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- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
- A history of papillary conjunctivitis that has interfered with contact lens wear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens
The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.
Read the detailed description
This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.
- Conditions
- Myopia
- Being tested
- Si-Hy (olifilcon B), Vistakon (narafilcon A)
- Keywords
- silicone hydrogel daily disposable soft contact lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Si-Hy (olifilcon B)Device
Wear Si-Hy silicone hydrgel soft contact lens for 3 months
Vistakon (narafilcon A)Device
Wear Vistakon soft contact lens for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Si-Hy soft contact lens | Experimental | olifilon B daily disposable soft contact lens Receives: Device: Si-Hy (olifilcon B) |
| Vistakon soft contact lens | Active comparator | narafilcon A daily disposable soft contact lens Receives: Device: Vistakon (narafilcon A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
logMAR visual acuity (VA) over all visits.
Measured: over all follow-up visits for 3 month study period
Secondary outcomes (2)
Any Slit Lamp Finding > Grade 2
All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.
Measured: over all follow-up visits for the 3 month study period
Subjective Response to Comfort, symptoms and complaints
subjective ratings of comfort, symptom and complaints using a scale of 0=severe stinging/Burning to 10=No stinging/Burning for each eye; 0 represented the least favorable rating and a 100 represented the most favorable rating.
Measured: over all follow-up visits for the 3 month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visco Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huey Chuan Cheng, MD MS, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676258
- Sponsor's protocol ID
- 1030313M
- Status last verified
- Jul 2016
- First submitted
- 30 Jan 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of Si-Hy Silicone Hydrogel Soft Contact Lens
- ClinicalTrials.gov ID
- NCT02676258
- Acronym / sponsor ID
- 1030313M
- Conditions
- Myopia
- Keywords
- silicone hydrogel daily disposable soft contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Visco Vision Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Feb 2016 (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.
The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.
Detailed description
This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Si-Hy soft contact lens | Experimental | Device: Si-Hy (olifilcon B)olifilon B daily disposable soft contact lens |
| Vistakon soft contact lens | Active comparator | Device: Vistakon (narafilcon A)narafilcon A daily disposable 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 (5 listed)
- Subject should have normal eyes and use no ocular medications
- Subject with -1.00 to -10.00 D myopia, less than 2.00 D astigmatism
- VA correctable to Log MAR 0.1 or better.
- Willing to comply with all study procedures and be available for the duration of the study.
- Provide signed and dated informed consent form.
Key exclusion criteria (9 listed)
- Subjects have history of allergies that would contraindicate "normal" contact lens wear.
- Subjects have other active ocular or systemic disease such as, but not limited to : anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes.
- Subjects have medications that would contraindicate contact lens wear.
- Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
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 |
|---|---|---|
| Si-Hy (olifilcon B)Wear Si-Hy silicone hydrgel soft contact lens for 3 months | Device | Si-Hy soft contact lens |
| Vistakon (narafilcon A)Wear Vistakon soft contact lens for 3 months | Device | Vistakon soft contact lens |
Primary outcome
Visual Acuity
Time frame: over all follow-up visits for 3 month study period
logMAR visual acuity (VA) over all visits.
2 secondary outcomes
Any Slit Lamp Finding > Grade 2
Time frame: over all follow-up visits for the 3 month study period
Subjective Response to Comfort, symptoms and complaints
Time frame: over all follow-up visits for the 3 month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- 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.
Huey Chuan Cheng, MD MS principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Si-Hy (olifilcon B) and Vistakon (narafilcon A) in people with Myopia, run by Visco Vision Inc. at 1 site in Taiwan.
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 5 inclusion and 9 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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Acuity (time frame: over all follow-up visits for 3 month study period). 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 Jul 2016.