MyopiaNCT06128486
Clinical Evaluation of the Safety and Efficacy of Yung Sheng 55 % Color Contact Lens
A study testing Soft Contact Lens in people with Myopia, run by Yung Sheng Optical Co., Ltd..
Trial summary
This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 55% Color Contact Lens for vision correction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Soft Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2012to 17 Mar 2014
- 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
- The subject must sign the informed consent form.
- The subject must be at least 20 years of age as of the date of evaluation for the study.
- The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
- The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
- The subject must have normal eyes, except ametropia.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must appear able and willing to fill the daily card.
Who cannot join
- The subjects who need to use ophthalmic medicine for therapy.
- The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
- The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
- The subjects who have clinically significant tear secretion abnormal.
- The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.
About this study
This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 55% Color Contact Lens for vision correction.
- Conditions
- Myopia
- Being tested
- 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.
Soft Contact LensDevice
Vision Correction
| Study group | Role | What they receive |
|---|---|---|
| Yung Sheng 55% Color Contact Lens | Experimental | Not described Receives: Device: Soft Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of corrected visual acuity
The visual acuity after contact lens correction should be more than or equal to 1.0 at the final visit for each subject. The percentage of successful contact lens correction of visual acuity should be more than 90 % among all subjects.
Measured: 3 Months
Secondary outcomes (3)
Lens fitting (Lens position)
Lens position should be "in the middle of eyes". The successful percentage among all subjects should be more than 80 %.
Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF.
Measured: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Lens fitting (Lens movement)
Lens movement should be less than "1.5 mm". The successful percentage among all subjects should be more than 80 %.
Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF.
Measured: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Lens fitting (Lens edge)
Lens edge should be normal after wearing. The successful percentage among all subjects should be more than 80 %.
Slit-lamp biomicroscopy will be assessed according to the approved study biomicroscopy CRF.
Measured: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start25 Aug 2012
- Primary completion17 Mar 2014
- Study completion17 Mar 2014
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Sheng Optical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huey-Chuan Cheng, MD / MS, Principal investigator, Mackay Memorial HospitalMing-Cheng TAI, MD, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128486
- Sponsor's protocol ID
- CE-120410
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of Yung Sheng 55 % Color Contact Lens
- ClinicalTrials.gov ID
- NCT06128486
- Acronym / sponsor ID
- CE-120410
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yung Sheng Optical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2012 (actual)
- Primary completion
- 17 Mar 2014 (actual)
- Study completion
- 17 Mar 2014 (actual)
- First posted
- 13 Nov 2023 (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 was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 55% Color Contact Lens for vision correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yung Sheng 55% Color Contact Lens | Experimental | Device: 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 (7 listed)
- The subject must sign the informed consent form.
- The subject must be at least 20 years of age as of the date of evaluation for the study.
- The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
- The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
- The subject must have normal eyes, except ametropia.
Key exclusion criteria (5 listed)
- The subjects who need to use ophthalmic medicine for therapy.
- The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
- The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
- The subjects who have clinically significant tear secretion abnormal.
- The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.
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 |
|---|---|---|
| Soft Contact LensVision Correction | Device | Yung Sheng 55% Color Contact Lens |
Primary outcome
The effectiveness of corrected visual acuity
Time frame: 3 Months
The visual acuity after contact lens correction should be more than or equal to 1.0 at the final visit for each subject. The percentage of successful contact lens correction of visual acuity should be more than 90 % among all subjects.
3 secondary outcomes
Lens fitting (Lens position)
Time frame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Lens fitting (Lens movement)
Time frame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
Lens fitting (Lens edge)
Time frame: Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months
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 13 Nov 2023.
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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
Ming-Cheng TAI, MD principal investigator
Tri-Service General Hospital (TSGH)
Questions about this trial
What is this clinical trial studying?
A study testing Soft Contact Lens in people with Myopia, run by Yung Sheng Optical Co., Ltd..
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 7 inclusion and 5 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 13 Nov 2023. 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?
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?
The effectiveness of corrected 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 13 Nov 2023.