MyopiaNCT03934788
the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens
A study testing oxysoft (olifilcon C) and Si-Hy (olifilcon B) in people with Myopia, run by Visco Vision Inc. at 3 sites in Taiwan.
Trial summary
The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- oxysoft (olifilcon C) and Si-Hy (olifilcon B)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesTaiwan
- Study dates
- 26 Sep 2018to 29 Nov 2018
- 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 eye and use no ocular medications
- VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =< 2.00 D
- 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, slip lamp findings greater than grade I (such as cornea or interstitial edema).
- Subjects have medications that would contraindicate contact lens wear.
- 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.
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- Any active participation in another clinical trial within 30 days prior to this study.
- Have had any cornea surgery.
- Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 1 month.
- Monocular or monovision fits
- Alcoholic or Drug Abused.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Taipei TzuChi Hopsital, Buddhist Tzu Chi Medical Foundation
New Taipei City, 231
Tri-Service General Hospital_Tingjhou
Taipei, 100
MayKay Memorial Hospital
Taipei, 10449
About this study
Official title: A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens
The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.
Read the detailed description
This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.
- Conditions
- Myopia
- Being tested
- oxysoft (olifilcon C), Si-Hy (olifilcon B)
- Keywords
- contact lens material, silicon hydrogel
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxysoft (olifilcon C)Device
subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.
Si-Hy (olifilcon B)Device
subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.
| Study group | Role | What they receive |
|---|---|---|
| Oxysoft | Experimental | olifilcon C, daily disposable soft contact lens, 1 month Receives: Device: oxysoft (olifilcon C) |
| SiHy | Active comparator | olifilcon B, dialy disposable soft contact lens, 1 month Receives: Device: Si-Hy (olifilcon B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log MAR visual acuities
The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.
Measured: 1 month
Secondary outcomes (1)
slit lamp findings
Any slit lamp findings > grade 2 [ Time Frame: over all follow-up visits for the 1 month ] slit lamp findings on all dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=sever findings.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start26 Sep 2018
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visco Vision Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jens Medical Consulting Ltd.
- Responsible party
- Sponsor
- Investigators
- Huey Chuan Cheng, MD MSc, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934788
- Sponsor's protocol ID
- 1060510M
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2019
- Last updated
- 2 May 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 2 May 2019. 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 OxySoft Silicone Hydrogel Soft Contact Lens
- ClinicalTrials.gov ID
- NCT03934788
- Acronym / sponsor ID
- 1060510M
- Conditions
- Myopia
- Keywords
- contact lens material, silicon hydrogel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Visco Vision Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jens Medical Consulting Ltd.
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 2 May 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 objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.
Detailed description
This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation.
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 |
|---|---|---|
| Oxysoft | Experimental | Device: oxysoft (olifilcon C)olifilcon C, daily disposable soft contact lens, 1 month |
| SiHy | Active comparator | Device: Si-Hy (olifilcon B)olifilcon B, dialy disposable soft contact lens, 1 month |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject should have normal eye and use no ocular medications
- VA correctable to 0.1 LogMAR or better, with spherical lenses ranging in power from -1.00 to -10.00 D myopia, astigmatism =< 2.00 D
- 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 (11 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, slip lamp findings greater than grade I (such as cornea or interstitial edema).
- Subjects have medications that would contraindicate contact lens wear.
- 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.
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 |
|---|---|---|
| oxysoft (olifilcon C)subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality. | Device | Oxysoft |
| Si-Hy (olifilcon B)subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality. | Device | SiHy |
Primary outcome
Log MAR visual acuities
Time frame: 1 month
The primary efficacy will be Log MAR visual acuities (VA) of 0.1 or better.
1 secondary outcome
slit lamp findings
Time frame: 1 month
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 2 May 2019.
- 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 MSc principal investigator
Mackay Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxysoft (olifilcon C) and Si-Hy (olifilcon B) in people with Myopia, run by Visco Vision Inc. at 3 sites 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 4 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: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Log MAR visual acuities (time frame: 1 month). 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 2 May 2019.