Soft Contact LensNCT05733884
Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial
A study testing soft contact lens in people with Soft Contact Lens, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
A prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. The newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn… Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Contact Lens
- What is being tested?
- soft contact lens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2020to 4 May 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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects must be between the ages of 8 and 15 (both 8 and 15 years old).
- Subject's best corrected visual acuity must be at least LogMAR 0.10 or higher in both eyes.
- The subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics.
- Based on the slit-lamp examination results of the screening clinic, determined that the infection of the conjunctiva, eyelids and accessory organs was less than Grade 2 (mild).
- No structural abnormality of the eyelid, conjunctiva or accessory organ tissue.
- Slit lamp findings must be less than Grade 1 (mild) and the cornea must not show: edema, staining, clouding, or vascularization according to the slit lamp findings of the screening clinic.
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- No iritis.
- There are no other active eye diseases that are not suitable for contact lens wear.
- No topical eye drops are currently being used.
- The subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form.
- Legal guardians of subjects under 12 years of age are willing to sign the informed consent form.
- Meet the following refractive criteria determined by cycloplegic autorefraction at baseline
- Spherical equivalent refractive error: between -0.75 and -6.00 D inclusive
- Astigmatism: ≤-0.75 D
- Anisometropia: <1.00 D
Who cannot join
- Participants with certain eye diseases that may affect their eye health or may be aggravated by the test product.
- Those who are unable to comply with regular tracking and inspection.
- Subject is currently participating, or has participated in another drug trial within 4 weeks prior to enrollment in this trial.
- Subject has undergone any eye surgery or corneal surgery.
- Subject has used systemic steroids, other systemic medications that may significantly affect vision or recovery, ophthalmic steroids, eye ointments, or pupil dilators (except for examination pupil dilators) within 2 weeks prior to trial entry.
- Those who are unable to cooperate with regular tracking and inspection.
- Participants with poor hygiene practices that may compromise safety during the trial or be inconsistent with the participant's best interests.
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. The newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn for at least 8 hours per day, 7 days a week, for a period of 1 year. All contact lenses were replaced with new lenses every day. Measurements obtained using a LogMAR vision meter, including automated computerised optometry, handheld retinoscopy, high (96%) and low (12%) contrast sensitivity visual acuity values at a distance, and near-visible acuity values were used to evaluate the corneal curvature using a corneal mapper. Additionally, the axial length(AXL) of the eye was measured, and the tear quality was assessed using a slit lamp, including tear break-up time, tear river height, and observation of blink frequency. Furthermore, the eye's anterior surface was examined by slit lamp using the Efron grading scale.
- Conditions
- Soft Contact Lens
- Being tested
- soft contact lens
- Keywords
- axial length, children, myopia control, soft contact lens, clinical trials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft contact lensOther
soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan | Experimental | Subjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months. Receives: Other: soft contact lens |
| Omafilcon A, dual-focus optical design, USA | Active comparator | Subjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months. Receives: Other: soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical Equivalent Refraction (SER)
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
Measured: 12 months
Secondary outcomes (1)
Axial Eye Length (AXL)
The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start9 Dec 2020
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Contact LensStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min yen Hsu, PhD, Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733884
- Sponsor's protocol ID
- CS1-20136
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2023
- Last updated
- 21 Feb 2023
- 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 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial
- ClinicalTrials.gov ID
- NCT05733884
- Acronym / sponsor ID
- CS1-20136
- Conditions
- Soft Contact Lens
- Keywords
- axial length, children, myopia control, soft contact lens, clinical trials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 17 Feb 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.
A prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. The newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn for at least 8 hours per day, 7 days a week, for a period of 1 year. All contact lenses were replaced with new lenses every day. Measurements obtained using a LogMAR vision meter, including automated computerised optometry, handheld retinoscopy, high (96%) and low (12%) contrast sensitivity visual acuity values at a distance, and near-visible acuity values were used to evaluate the corneal curvature using a corneal mapper. Additionally, the axial length(AXL) of the eye was measured, and the tear quality was assessed using a slit lamp, including tear break-up time, tear river height, and observation of blink frequency. Furthermore, the eye's anterior surface was examined by slit lamp using the Efron grading scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan | Experimental | Other: soft contact lensSubjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months. |
| Omafilcon A, dual-focus optical design, USA | Active comparator | Other: soft contact lensSubjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Subjects must be between the ages of 8 and 15 (both 8 and 15 years old).
- Subject's best corrected visual acuity must be at least LogMAR 0.10 or higher in both eyes.
- The subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics.
- No topical eye drops are currently being used.
- The subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form.
Key exclusion criteria (7 listed)
- Participants with certain eye diseases that may affect their eye health or may be aggravated by the test product.
- Those who are unable to comply with regular tracking and inspection.
- Subject is currently participating, or has participated in another drug trial within 4 weeks prior to enrollment in this trial.
- Subject has undergone any eye surgery or corneal surgery.
- Subject has used systemic steroids, other systemic medications that may significantly affect vision or recovery, ophthalmic steroids, eye ointments, or pupil dilators (except for examination pupil dilators) within 2 weeks prior to trial entry.
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 lenssoft contact lens | Other | Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan, Omafilcon A, dual-focus optical design, USA |
Primary outcome
Spherical Equivalent Refraction (SER)
Time frame: 12 months
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
1 secondary outcome
Axial Eye Length (AXL)
Time frame: 12 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 21 Feb 2023.
- 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.
Min yen Hsu, PhD study director
Chung Shan Medical University
1 site 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 Soft Contact Lens, run by Chung Shan Medical University at 1 site 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 15 inclusion and 7 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 21 Feb 2023. 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 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?
Spherical Equivalent Refraction (SER) (time frame: 12 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 21 Feb 2023.