MyopiaNCT03413085
To Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control
A study testing soft contact lens in people with Myopia, run by Largan Medical Co., Ltd. at 3 sites in Taiwan.
Trial summary
The objective of this study is to investigate the efficacy and safety of soft lens in myopia control. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- 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
- 59 participants
- Where
- 3 sitesTaiwan
- Study dates
- 2 May 2018to 5 Mar 2020
- 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 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Both genders aged between 6 and 15 years
- Spherical equivalent refractive error between -1.00D and -10.00D
- Visual acuity with contact lens of 20/25 or better in each eye
- Astigmatism less than or equal to 1.50D
- Anisometropia less than or equal to 1.00D
- Agree to wear assigned contact lens and able to comply with the study protocol
- Subjects and/or their legal representatives agree to sign informed consent form
Who cannot join
- Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example:
- Amblyopia
- Severe strabismus at investigator's discretion
- Pathologically dry eye
- Aphakia
- Slit lamp findings including but not limited to corneal edema, corneal ulcer, bulbar redness that are more serious than grade 1
Show all 17Show fewer
- Currently ocular infection of any type or inflammation in either eye
- Oculomotor nerve palsies
- Pupil or lid abnormality in either eye
- Severe ocular allergy
- Anterior segment infection, inflammation or abnormality
- Corneal vascularization greater than 1 mm of penetration
- History of herpetic keratitis
- Use of bifocals, progressive addition lenses, rigid gas permeable contact lenses, orthokeratology lenses, atropine, pirenzepine or any other myopia control treatment within 1 month prior to screening visit
- Systemic disease that may affect vision or contact lens wearing (e.g. diabetes, Down syndrome), autoimmune disease, infectious disease, or immunosuppressive diseases recorded in medical charts or informed by caregiver
- Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery)
- Receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methyphenidate)
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Tzu-Hsun Tsai M.D.
Taipei, 100
Ken-Kuo Lin M.D.
Taipei, 105
Jiahn-Shing Lee M.D.
Taoyuan, 333
About this study
Official title: A Prospective, Randomization, Double-blind Study to Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control
The objective of this study is to investigate the efficacy and safety of soft lens in myopia control.
Read the detailed description
This is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate the efficacy and safety of "Soft Lens" in myopia control among schoolchildren. A total of 118 eyes are planned to be enrolled and the expect duration of subject participation will be 48 weeks not including two weeks of screening period. Data such as refractive error, axial length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be collected during the study. A total of 10 visits, i.e. a screening visit, a randomization visit, and 8 treatment visits are planned. Subjects will be encouraged to complete all planned visits.
- Conditions
- Myopia
- Being tested
- soft contact lens
- Keywords
- Myopia control
- 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
Group A
Group B
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Intervention name: multifocal soft contact lens/single vision soft contact lens
Left eye: multifocal soft contact lens Right eye: single vision soft contact lens Receives: Device: soft contact lens |
| Group B | Other | Intervention name: multifocal soft contact lens/single vision soft contact lens
Left eye: single vision soft contact lens Right eye: multifocal soft contact lens Receives: Device: soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cycloplegic refractive error
Changes in objective cycloplegic refractive error between the two eyes in 48 weeks
Measured: 48 weeks
Axial length
Changes in axial length between the two eyes in 48 weeks
Measured: 48 weeks
Secondary outcomes (6)
Cycloplegic refractive error
Changes in objective cycloplegic refractive error between the two eyes from baseline after treatment
Measured: 12, 24, and 36 weeks
Axial length
Changes in axial length between the two eyes from baseline after treatment
Measured: 12, 24, and 36 weeks
Myopia progression and axial elongation
Percent reductions of myopia progression and axial elongation
Measured: during 48 weeks
Self-assessment by questionnaire 1
Analysis of subject self-assessment
Measured: during 48 weeks
Self-assessment by questionnaire 2
Average wearing hours across the study period
Measured: during 48 weeks
Self-assessment by questionnaire 3
Reasons and rate for discontinued wear during the study period
Measured: during 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start2 May 2018
- Primary completion31 Dec 2019
- Study completion5 Mar 2020
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
- Model description
- Paired-eye comparison
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Largan Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tzu-Hsun Tsai, M.D., Study chair, National Taiwan University HospitalTzu-Hsun Tsai, M.D., Principal investigator, National Taiwan University HospitalChao-Wen Lin, M.D., Principal investigator, National Taiwan University HospitalKen-Kuo Lin, M.D., Principal investigator, Taipei Chang Gung Memorial HospitalJiahn-Shing Lee, M.D., Principal investigator, Chang Gung Memorial HospitalChiun-Ho Hou, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413085
- Sponsor's protocol ID
- LMO00-CL-DM-01
- Status last verified
- Mar 2020
- First submitted
- 21 Jan 2018
- Last updated
- 12 Mar 2020
- 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 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomization, Double-blind Study to Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control
- ClinicalTrials.gov ID
- NCT03413085
- Acronym / sponsor ID
- LMO00-CL-DM-01
- Conditions
- Myopia
- Keywords
- Myopia control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Largan Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital, Chang Gung Memorial Hospital
- Study start
- 2 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 29 Jan 2018 (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 investigate the efficacy and safety of soft lens in myopia control.
Detailed description
This is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate the efficacy and safety of "Soft Lens" in myopia control among schoolchildren. A total of 118 eyes are planned to be enrolled and the expect duration of subject participation will be 48 weeks not including two weeks of screening period. Data such as refractive error, axial length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be collected during the study. A total of 10 visits, i.e. a screening visit, a randomization visit, and 8 treatment visits are planned. Subjects will be encouraged to complete all planned visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Paired-eye comparison
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: soft contact lensIntervention name: multifocal soft contact lens/single vision soft contact lens Left eye: multifocal soft contact lens Right eye: single vision soft contact lens |
| Group B | Other | Device: soft contact lensIntervention name: multifocal soft contact lens/single vision soft contact lens Left eye: single vision soft contact lens Right eye: multifocal soft contact lens |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Both genders aged between 6 and 15 years
- Spherical equivalent refractive error between -1.00D and -10.00D
- Visual acuity with contact lens of 20/25 or better in each eye
- Astigmatism less than or equal to 1.50D
- Anisometropia less than or equal to 1.00D
Key exclusion criteria (17 listed)
- Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example:
- Use of bifocals, progressive addition lenses, rigid gas permeable contact lenses, orthokeratology lenses, atropine, pirenzepine or any other myopia control treatment within 1 month prior to screening visit
- Systemic disease that may affect vision or contact lens wearing (e.g. diabetes, Down syndrome), autoimmune disease, infectious disease, or immunosuppressive diseases recorded in medical charts or informed by caregiver
- Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery)
- Receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methyphenidate)
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 lensGroup A Group B | Device | Group A, Group B |
Primary outcome
Objective cycloplegic refractive error
Time frame: 48 weeks
Changes in objective cycloplegic refractive error between the two eyes in 48 weeks
Axial length
Time frame: 48 weeks
Changes in axial length between the two eyes in 48 weeks
6 secondary outcomes
Cycloplegic refractive error
Time frame: 12, 24, and 36 weeks
Axial length
Time frame: 12, 24, and 36 weeks
Myopia progression and axial elongation
Time frame: during 48 weeks
Self-assessment by questionnaire 1
Time frame: during 48 weeks
Self-assessment by questionnaire 2
Time frame: during 48 weeks
Self-assessment by questionnaire 3
Time frame: during 48 weeks
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 12 Mar 2020.
- 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.
Tzu-Hsun Tsai, M.D. study chair
National Taiwan University Hospital
Tzu-Hsun Tsai, M.D. principal investigator
National Taiwan University Hospital
Chao-Wen Lin, M.D. principal investigator
National Taiwan University 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 soft contact lens in people with Myopia, run by Largan Medical Co., Ltd. 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 7 inclusion and 17 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 12 Mar 2020. 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?
Objective cycloplegic refractive error (time frame: 48 weeks). The study lists 2 primary outcomes in all. 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 12 Mar 2020.