MyopiaNCT02354924
Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens
A study testing Biofinity soft contact lens and Visco soft contact lens in people with Myopia, run by Visco Vision Inc..
Trial summary
The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Biofinity soft contact lens and Visco soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Nov 2013
- 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 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 -1.25 D astigmatism
- VA correctable to 20/25 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 solution use and/or "normal" contact lens wear.
- Cornea sensitivity low, high myopes, Keratoconus, dry eye with Schirmer Test < 5mm/5min or other physical condition that would contraindicate contact lens wear.
- Subjects have other active ocular or systemic disease that would contraindicate contact lens wear.
- Subjects have medications that would contraindicate contact lens wear.
- Females who are pregnant, breastfeeding, birth control pill taken or who intended to become pregnant over the course of the study.
- Current drug or alcohol use or dependence that would interfere with adherence to study requirements.
- Individuals participating in other clinical studies.
About this study
Official title: A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of VISCO Soft Contact Lens on a Daily Wear Basis
The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.
Read the detailed description
This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).
- Conditions
- Myopia
- Being tested
- Biofinity soft contact lens, Visco 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.
Biofinity soft contact lensDevice
Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Visco soft contact lensDevice
Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Visco soft contact lens | Experimental | Olifilcon A, Daily wear, monthly disposable soft contact lens Receives: Device: Visco soft contact lens |
| Biofinity soft contact lens | Active comparator | Comfilcon A, Daily wear, monthly disposable soft contact lens Receives: Device: Biofinity soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Visual acuity correctable to snellen 20/25 or better
Measured: 3 months
Secondary outcomes (2)
Slit Lamp Findings
Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings
Measured: 3 month
Symptoms, Problems and Complaints and Incidence Rate
Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startJun 2013
- Primary completionNov 2013
- Study completionNov 2013
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 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
- Double blind
- Who is masked
- Participant, Investigator
- 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, Mackey Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354924
- Sponsor's protocol ID
- 1000601M
- Status last verified
- Mar 2017
- First submitted
- 29 Jan 2015
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. 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 VISCO Soft Contact Lens on a Daily Wear Basis
- ClinicalTrials.gov ID
- NCT02354924
- Acronym / sponsor ID
- 1000601M
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Visco Vision Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 14 Apr 2017
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 demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.
Detailed description
This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visco soft contact lens | Experimental | Device: Visco soft contact lensOlifilcon A, Daily wear, monthly disposable soft contact lens |
| Biofinity soft contact lens | Active comparator | Device: Biofinity soft contact lensComfilcon A, Daily wear, monthly 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 -1.25 D astigmatism
- VA correctable to 20/25 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 (7 listed)
- Subjects have history of allergies that would contraindicate solution use and/or "normal" contact lens wear.
- Cornea sensitivity low, high myopes, Keratoconus, dry eye with Schirmer Test < 5mm/5min or other physical condition that would contraindicate contact lens wear.
- Subjects have other active ocular or systemic disease that would contraindicate contact lens wear.
- Subjects have medications that would contraindicate contact lens wear.
- Females who are pregnant, breastfeeding, birth control pill taken or who intended to become pregnant over the course of the study.
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 |
|---|---|---|
| Biofinity soft contact lensBiofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days. | Device | Biofinity soft contact lens |
| Visco soft contact lensViso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days. | Device | Visco soft contact lens |
Primary outcome
Visual Acuity
Time frame: 3 months
Visual acuity correctable to snellen 20/25 or better
2 secondary outcomes
Slit Lamp Findings
Time frame: 3 month
Symptoms, Problems and Complaints and Incidence Rate
Time frame: 3 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- 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.
Huey Chuan Cheng, MD. MS principal investigator
Mackey Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Biofinity soft contact lens and Visco soft contact lens in people with Myopia, run by Visco Vision Inc..
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 7 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 14 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 14 Apr 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?
Visual Acuity (time frame: 3 months). 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 14 Apr 2017.