MyopiaNCT06616519
A Study to Evaluate the Safety and Efficacy of MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses
A study testing BenQ Materials MSENCI soft hydrophilic contact lenses and Visco Oxypure 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 MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product. 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 MSENCI soft hydrophilic contact lenses and Visco Oxypure 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
- 18 May 2021to 25 Aug 2022
- 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, no gender limitation;
- Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D;
- Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia;
- The optimal binocular CVA with glasses ≥ 1.0;
- The astigmatism should be ≤1.5D;
- Binoculus BUT \>5s;
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- should accept follow-ups for at least 90 days and wear the contact lens as required in the protocol;
- should understand the purpose of the trial, volunteer to attend and sign the Informed Consent Form by the subjects themselves or their legal guardians.
- .
Who cannot join
- Patients who suffer from systemic diseases that prohibit contact lens use or receive treatment that may affect the vision or contact lens use;
- Patients who have worn hard contact lenses within 4 weeks or soft contact lenses within 7 days before being included in the trial;
- Patients who are allergic to contact lenses or suffer from systemic allergy;
- Patients who have keratoconus or other cornea irregularity;
- Patients who always stay at places that are dry, dust-heavy, having volatile chemicals or otherwise affect the use of soft hydrophilic contact lenses;
- People who are pregnant, during their lactation or prepare for the pregnancy while being included;
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- People who have only a single eye qualified for the trial;
- People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;
- People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;
- Other cases where investigators determine the soft contact lens should not be used or the candidate should be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Open, Parallel, and Randomly Controlled Comparison Between MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses in Their Safety and Efficacy
This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product.
- Conditions
- Myopia
- Being tested
- BenQ Materials MSENCI soft hydrophilic contact lenses, Visco Oxypure 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 MSENCI soft hydrophilic contact lensesDevice
Test lenses were to be worn for approximately 90 days.
Visco Oxypure Color soft hydrophilic contact lensesDevice
Control lenses were to be worn for approximately 90 days
| Study group | Role | What they receive |
|---|---|---|
| BenQ Materials MSENCI lenses | Experimental | BenQ Materials Daily disposable contact lens wears for 1 month Receives: Device: BenQ Materials MSENCI soft hydrophilic contact lenses |
| Visco Oxypure lens | Active comparator | Not described Receives: Device: Visco Oxypure 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
Binocular CVA with lenses after wearing lenses, 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 lens
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 start18 May 2021
- Primary completion1 May 2022
- Study completion25 Aug 2022
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
- NCT06616519
- Sponsor's protocol ID
- MSENC1 202101
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 27 Sep 2024
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Open, Parallel, and Randomly Controlled Comparison Between MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses in Their Safety and Efficacy
- ClinicalTrials.gov ID
- NCT06616519
- Acronym / sponsor ID
- MSENC1 202101
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- BenQ Materials CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 25 Aug 2022 (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 MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BenQ Materials MSENCI lenses | Experimental | Device: BenQ Materials MSENCI soft hydrophilic contact lensesBenQ Materials Daily disposable contact lens wears for 1 month |
| Visco Oxypure lens | Active comparator | Device: Visco Oxypure 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 (9 listed)
- Age ≥ 18 years old, no gender limitation;
- Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D;
- Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia;
- The optimal binocular CVA with glasses ≥ 1.0;
- The astigmatism should be ≤1.5D;
Key exclusion criteria (10 listed)
- Patients who suffer from systemic diseases that prohibit contact lens use or receive treatment that may affect the vision or contact lens use;
- Patients who have worn hard contact lenses within 4 weeks or soft contact lenses within 7 days before being included in the trial;
- Patients who are allergic to contact lenses or suffer from systemic allergy;
- Patients who have keratoconus or other cornea irregularity;
- Patients who always stay at places that are dry, dust-heavy, having volatile chemicals or otherwise affect the use of soft hydrophilic contact lenses;
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 MSENCI soft hydrophilic contact lensesTest lenses were to be worn for approximately 90 days. | Device | BenQ Materials MSENCI lenses |
| Visco Oxypure Color soft hydrophilic contact lensesControl lenses were to be worn for approximately 90 days | Device | Visco Oxypure lens |
Primary outcome
efficacy evaluation indexes
Time frame: after wearing lenses for 7 days
Binocular CVA with lenses after wearing lenses, 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 MSENCI soft hydrophilic contact lenses and Visco Oxypure 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 9 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.