MyopiaNCT06121531
A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone Hydrogel Monthly Soft Contact Lens for the Safety and Effectiveness in Visual Correction.
A study testing Soft Contact Lens in people with Myopia, run by Yung Sheng Optical Co., Ltd. at 2 sites in Taiwan.
Trial summary
This was a prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel 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
- 144 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Feb 2021to 28 Sep 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years old and above.
- Subjects with normal eyes who are not using any ocular medications (excluding ocular lubricants and artificial tears).
- Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes.
- With +6.00D ~ -12.00 D spherical power, and ≦1.00 D astigmatism (based on subjective optometry measurements).
- Have worn soft contact lens for at least 1 month prior to the study.
- Willing to comply with the required wearing time and use specified contact lens care product.
- Agree to comply with all study procedures and signed the informed consent form before enrollment.
Who cannot join
- Anterior chamber infection, inflammation, or abnormality.
- Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings.
- Currently using systemic or ocular medications that would contraindicate with contact lens wear (such as, glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines).
- History of herpes simplex keratitis.
- History of refractive surgery, keratoconus, or irregular cornea.
- Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5 from page 38 to 43).
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- A pathologically dry eye syndrome (Schirmer test < 5 mm).
- Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection).
- Currently pregnant or lactation.
- Allergy to any contact lens care product ingredient (such as mercury or topical antimicrobial agent).
- Have experienced discomfort when wearing hydrogel contact lens.
- Subjects who are judged unsuitable for the study by the investigators.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Tri-Service General Hospital
Taipei, 114202
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
About this study
This was a prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel 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 |
|---|---|---|
| Group I | Active comparator | Si-Hy (Samfilcon A) Receives: Device: Soft Contact Lens |
| Group II | Experimental | Si-Hy (Otufilcon A) 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 effectiveness of corrected visual acuity at 3-month. Effectiveness is defined as visual acuities of both eyes correctable to ≥1.0 with contact lens.
Effectiveness formula (%): total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %.
Definition of total number of subjects enrolled at a given time: the total number of subjects conforming to the PPS criteria and having worn lenses for 3 months.
Measured: 3 Months
Secondary outcomes (8)
Effectiveness of corrected visual acuity
Effectiveness of corrected visual acuity at 1 week, 1 month and 2 months. The effectiveness (%) is defined as total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %.
Measured: 1 week, 1 month and 2 months
Average contact lens corrected visual acuity
The mean, standard deviation, median, maximum, minimum, Q1, Q3 and Inter-Quartile Range (IQR) will be calculated for "Lens corrected visual acuity". Comparisons between the Treatment group and Control group will be made.
Measured: 1 week, 1 month, 2 months and 3 months
Change in diopter (Spherical and cylindrical power of subjective optometry)
The mean, standard deviation, median, maximum, minimum, Q1, Q3 and Inter-Quartile Range (IQR) will be calculated for "power" (the spherical and cylindrical power). Comparisons between the Treatment group and Control group will be made.
Measured: 1 week, 1 month, 2 months and 3 months
Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism)
The mean, standard deviation, median, maximum, minimum, Q1, Q3, and Inter-Quartile Range (IQR) will be calculated for "corneal astigmatism" (the vertical and horizontal curvature, the power and axis of astigmatism).
Comparisons between the Treatment group and Control group will be made.
Measured: 1 week, 1 month, 2 months and 3 months
Lens broken rate
The number and percentage of parameters (total lenses, unbroken lenses, broken lenses) will be calculated and analyzed.
Comparisons between the Treatment group and Control group will be made.
Measured: 1 week, 1 month, 2 months and 3 months
Lens fitting (lens centration, lens movement, coverage, and tightness)
The total number and percentage of parameters (lens centration, lens movement, coverage, tightness) with grading scale evaluated by investigators will be calculated and analyzed.
Comparisons between the Treatment group and Control group will be made.
Measured: 1 week, 1 month, 2 months and 3 months
Subjective acceptance (comfort, vision, lens handling, lens cleaning)
The total number and percentage of parameters (comfort, vision, lens handling, lens cleaning) with a grading scale using questionnaires will be calculated and analyzed.
Comparisons between the Treatment group and Control group will be made.
Measured: 1 week, 1 month, 2 months and 3 months
Lens state (lens front surface wettability, front surface deposits, back surface deposits)
The total number and percentage of parameters (lens front surface wettability, front surface deposits, back surface deposits) with a grading scale evaluated by investigators will be calculated and analyzed.
Comparisons between the Treatment group and Control group will be made.
Measured: 1 week, 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 posted8 Nov 2023
- Study start1 Feb 2021
- Primary completion28 Sep 2022
- Study completion28 Sep 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung Sheng Optical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121531
- Sponsor's protocol ID
- 0438TC01
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 8 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Study of Silicone Hydrogel Monthly Soft Contact Lens for the Safety and Effectiveness in Visual Correction.
- ClinicalTrials.gov ID
- NCT06121531
- Acronym / sponsor ID
- 0438TC01
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Yung Sheng Optical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 8 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 prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel Contact Lens for vision correction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: Soft Contact LensSi-Hy (Samfilcon A) |
| Group II | Experimental | Device: Soft Contact LensSi-Hy (Otufilcon A) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 20 years old and above.
- Subjects with normal eyes who are not using any ocular medications (excluding ocular lubricants and artificial tears).
- Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes.
- With +6.00D ~ -12.00 D spherical power, and ≦1.00 D astigmatism (based on subjective optometry measurements).
- Have worn soft contact lens for at least 1 month prior to the study.
Key exclusion criteria (12 listed)
- Anterior chamber infection, inflammation, or abnormality.
- Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings.
- Currently using systemic or ocular medications that would contraindicate with contact lens wear (such as, glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines).
- History of herpes simplex keratitis.
- History of refractive surgery, keratoconus, or irregular cornea.
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 | Group I, Group II |
Primary outcome
The effectiveness of corrected visual acuity
Time frame: 3 Months
The effectiveness of corrected visual acuity at 3-month. Effectiveness is defined as visual acuities of both eyes correctable to ≥1.0 with contact lens. Effectiveness formula (%): total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %. Definition of total number of subjects enrolled at a given time: the total number of subjects conforming to the PPS criteria and having worn lenses for 3 months.
8 secondary outcomes
Effectiveness of corrected visual acuity
Time frame: 1 week, 1 month and 2 months
Average contact lens corrected visual acuity
Time frame: 1 week, 1 month, 2 months and 3 months
Change in diopter (Spherical and cylindrical power of subjective optometry)
Time frame: 1 week, 1 month, 2 months and 3 months
Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism)
Time frame: 1 week, 1 month, 2 months and 3 months
Lens broken rate
Time frame: 1 week, 1 month, 2 months and 3 months
Lens fitting (lens centration, lens movement, coverage, and tightness)
Time frame: 1 week, 1 month, 2 months and 3 months
Subjective acceptance (comfort, vision, lens handling, lens cleaning)
Time frame: 1 week, 1 month, 2 months and 3 months
Lens state (lens front surface wettability, front surface deposits, back surface deposits)
Time frame: 1 week, 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 8 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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. at 2 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 7 inclusion and 12 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 8 Nov 2023.