MyopiaNCT06616480
A Study to Evaluate the Safety and Efficacy of DSFNC1 Soft Hydrophilic Contact Lenses and SiHy Color Soft Hydrophilic Contact Lenses
A study testing BenQ Materials DSFNC1 soft hydrophilic contact lenses and Visco SiHy Color soft hydrophilic contact lenses in people with Myopia, run by BenQ Materials Corporation at 1 site in China.
Trial summary
This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- BenQ Materials DSFNC1 soft hydrophilic contact lenses and Visco SiHy Color soft hydrophilic contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 3 Mar 2023to 20 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, gender is not limited;
- Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D;
- Both eyes were normal with no other abnormality or disease other than refractive error;
- Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses;
- Astigmatism ≤ 2.0D;
- T5ar film break-up time (BUT) \>5s in both eyes
- Those who are able to complete a minimum of 90 days of follow-up and are able to wear contact lenses as required by the protocol;
- Ability to understand the purpose of the trial, to participate voluntarily and to have Informed Consent signed by the subject himself/herself or his/her legal guardian.
Who cannot join
- Persons with any systemic condition that contraindicates the wearing of contact lenses, or who are receiving treatment that interferes with vision or the wearing of contact lenses;
- Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial;
- People who are allergic to contact lens, and people with systemic allergic diseases;
- Patients with conical corneas or other irregular corneas;
- Those who have to wear soft hydrophilic contact lenses for a long period of time under special circumstances such as dryness, severe dust or volatile chemicals;
- Those who are pregnant, breastfeeding, or planning a pregnancy at the time of enrollment;
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- Those who were eligible for enrollment in only one eye;
- Concurrent participation in other clinical trials or participation in a soft contact lens clinical trial of soft hydrophilic contact lenses within 10 days prior to enrollment in this trial
- Participants who have participated in a clinical trial of a drug or a medical device other than a contact lens within 3 months prior to enrollment in this trial;
- Other conditions that, in the judgment of the investigator, make wearing soft contact lenses unsuitable or preclude enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Open, Parallel, Randomized Controlled Comparison on the Safety and Efficacy Clinical Study of DSFNC1 Soft Hydrophilic Contact Lenses With SiHy Color Soft Hydrophilic Contact Lenses
This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses.
- Conditions
- Myopia
- Being tested
- BenQ Materials DSFNC1 soft hydrophilic contact lenses, Visco SiHy Color soft hydrophilic contact lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenQ Materials DSFNC1 soft hydrophilic contact lensesDevice
Test lenses were to be worn for approximately 90 days.
Visco SiHy Color soft hydrophilic contact lensesDevice
Control lenses were to be worn for approximately 90 days
| Study group | Role | What they receive |
|---|---|---|
| BenQ Materials DSFNC1 lenses | Experimental | BenQ Materials contact lens wears for daily disposable Receives: Device: BenQ Materials DSFNC1 soft hydrophilic contact lenses |
| Visco SiHy Color lens | Active comparator | Not described Receives: Device: Visco SiHy Color soft hydrophilic contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy evaluation indexes
The proportion of contact lens-corrected eyesight, The percentage of changes in iris color
Measured: after wearing lenses for 7 days
Secondary outcomes (3)
Time of Break up time (BUT)
Comparison of BUT time results between the experimental group and control group
Measured: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Distance Uncorrected visual acuity (UCVA)
Comparison of distance uncorrected visual acuity results between the experimental group and control group
Measured: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Fitness of the contact
the position of lens on the ocular surface, the coverage, tightness and movability of len
Measured: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start3 Mar 2023
- Primary completion28 Mar 2024
- Study completion20 Jun 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- BenQ Materials Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616480
- Sponsor's protocol ID
- DSFNC1 202303
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open, Parallel, Randomized Controlled Comparison on the Safety and Efficacy Clinical Study of DSFNC1 Soft Hydrophilic Contact Lenses With SiHy Color Soft Hydrophilic Contact Lenses
- ClinicalTrials.gov ID
- NCT06616480
- Acronym / sponsor ID
- DSFNC1 202303
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- BenQ Materials CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 27 Sep 2024 (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.
This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BenQ Materials DSFNC1 lenses | Experimental | Device: BenQ Materials DSFNC1 soft hydrophilic contact lensesBenQ Materials contact lens wears for daily disposable |
| Visco SiHy Color lens | Active comparator | Device: Visco SiHy Color soft hydrophilic contact lenses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old, gender is not limited;
- Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D;
- Both eyes were normal with no other abnormality or disease other than refractive error;
- Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses;
- Astigmatism ≤ 2.0D;
Key exclusion criteria (10 listed)
- Persons with any systemic condition that contraindicates the wearing of contact lenses, or who are receiving treatment that interferes with vision or the wearing of contact lenses;
- Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial;
- People who are allergic to contact lens, and people with systemic allergic diseases;
- Patients with conical corneas or other irregular corneas;
- Those who have to wear soft hydrophilic contact lenses for a long period of time under special circumstances such as dryness, severe dust or volatile chemicals;
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 |
|---|---|---|
| BenQ Materials DSFNC1 soft hydrophilic contact lensesTest lenses were to be worn for approximately 90 days. | Device | BenQ Materials DSFNC1 lenses |
| Visco SiHy Color soft hydrophilic contact lensesControl lenses were to be worn for approximately 90 days | Device | Visco SiHy Color lens |
Primary outcome
Efficacy evaluation indexes
Time frame: after wearing lenses for 7 days
The proportion of contact lens-corrected eyesight, The percentage of changes in iris color
3 secondary outcomes
Time of Break up time (BUT)
Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Distance Uncorrected visual acuity (UCVA)
Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Fitness of the contact
Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
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 27 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BenQ Materials DSFNC1 soft hydrophilic contact lenses and Visco SiHy Color soft hydrophilic contact lenses in people with Myopia, run by BenQ Materials Corporation at 1 site in China.
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 8 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 27 Sep 2024. 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 China. 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?
Efficacy evaluation indexes (time frame: after wearing lenses for 7 days). 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 27 Sep 2024.