MyopiaNCT04299243
Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens
A study testing Contact Lenses in people with Myopia, run by Menicon Co., Ltd. at 1 site in China.
Trial summary
This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2018to 1 Jun 2019
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female with age of 18 to 45
- Spherical power: -0.25 to -10.00D
- Cylinder power ≤0.75D and Sph.P:Cyl.P≥3:1, or 1.00D≤ cylinder power ≤1.50D and Sph.P:Cyl.P ≥4:1;
- Both eyes are ametropia, and there is no case where the investigator believes that the soft contact lens cannot be worn;
- : The case of wearing a soft contact lens as referred to in this trial is: i) No eyelid abnormalities or infections; ii) No clinically significant slit lamp findings iii) No other active eye diseases.
- BCVA of the left and right eye subjective refraction is greater than or equal to 5.0.
Who cannot join
- Need to use therapeutic ophthalmic drugs, including antibiotics, hormones and compound ophthalmic drugs containing hormones
- Dry eye syndrome
- Any systemic disease contraindications to contact lenses or disease medications can affect the wearing of contact lenses
- Wearing a hard contact lens in the past 6 weeks
- Tear film break-up time is less than or equal to 5s
- Allergic to contact lenses and/or contact lenses
Show all 13Show fewer
- Keratoconus or other irregular corneal patients
- Soft hydrophilic contact lens wearers are affected by long-term special conditions such as dryness, severe dust or volatile chemicals
- Pregnant, lactating or plan to be pregnant
- Only one eye meets the requirements for enrollment
- Participating in other clinical trials or less than ten days after the end of a soft contact lens clinical trial
- Less than three months after the end of a drug clinical trial
- Determined by the investigator that could not be enrolled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens (Model: Spherical Lens)
This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.
Read the detailed description
The test product is the Soft Contact Lens (model: Spherical Lens), and the control product is a commercially available soft contact lens (model: SiHy Daily). The number of enrolled subjects is 148, and clinical observation is performed for 3 months.
- Conditions
- Myopia
- Being tested
- 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.
Contact LensesDevice
Contact lenses for vision correction
| Study group | Role | What they receive |
|---|---|---|
| Spherical Lens | Experimental | Randomized to Spherical Lens worn in a daily disposable mode Receives: Device: Contact Lenses |
| SiHy Daily | Active comparator | Randomized to SiHy Daily worn in a daily disposable mode Receives: Device: Contact Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of corrected visual acuity of left and right eyes is ≥5.0
The standard logarithmic visual acuity chart consistent with the guiding principle is adopted in this scheme.
- Success criteria: If the lower limit of 95% CI of the evaluated rate of corrected for visual acuity for both eyes ≥ 5.0 at 1 week visit is ≥-10%, the primary endpoint of the two groups is non-inferior.
Measured: 1 week
The occurrence of adverse events
Compare the number of adverse events and serious adverse events, the number of cases and the incidence rate; list the number and cases of adverse events; describe the adverse events that are related to the investigational products.
Measured: 3 month
Secondary outcomes (1)
BCVA (spectacles) and BCVA (CL)
BCVA (spectacles and CL) of both eyes are compared at baseline and at each follow-up.
Measured: 1 week, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start25 Nov 2018
- Primary completion15 May 2019
- Study completion1 Jun 2019
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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menicon Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Lihua, MD, Principal investigator, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299243
- Sponsor's protocol ID
- SLP-01
- Status last verified
- Mar 2020
- First submitted
- 18 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens (Model: Spherical Lens)
- ClinicalTrials.gov ID
- NCT04299243
- Acronym / sponsor ID
- SLP-01
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Menicon Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2018 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 6 Mar 2020 (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 a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.
Detailed description
The test product is the Soft Contact Lens (model: Spherical Lens), and the control product is a commercially available soft contact lens (model: SiHy Daily). The number of enrolled subjects is 148, and clinical observation is performed for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spherical Lens | Experimental | Device: Contact LensesRandomized to Spherical Lens worn in a daily disposable mode |
| SiHy Daily | Active comparator | Device: Contact LensesRandomized to SiHy Daily worn in a daily disposable mode |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female with age of 18 to 45
- Spherical power: -0.25 to -10.00D
- Cylinder power ≤0.75D and Sph.P:Cyl.P≥3:1, or 1.00D≤ cylinder power ≤1.50D and Sph.P:Cyl.P ≥4:1;
- Both eyes are ametropia, and there is no case where the investigator believes that the soft contact lens cannot be worn;
- : The case of wearing a soft contact lens as referred to in this trial is: i) No eyelid abnormalities or infections; ii) No clinically significant slit lamp findings iii) No other active eye diseases.
Key exclusion criteria (13 listed)
- Need to use therapeutic ophthalmic drugs, including antibiotics, hormones and compound ophthalmic drugs containing hormones
- Dry eye syndrome
- Any systemic disease contraindications to contact lenses or disease medications can affect the wearing of contact lenses
- Wearing a hard contact lens in the past 6 weeks
- Tear film break-up time is less than or equal to 5s
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 |
|---|---|---|
| Contact LensesContact lenses for vision correction | Device | SiHy Daily, Spherical Lens |
Primary outcome
The ratio of corrected visual acuity of left and right eyes is ≥5.0
Time frame: 1 week
The standard logarithmic visual acuity chart consistent with the guiding principle is adopted in this scheme. - Success criteria: If the lower limit of 95% CI of the evaluated rate of corrected for visual acuity for both eyes ≥ 5.0 at 1 week visit is ≥-10%, the primary endpoint of the two groups is non-inferior.
The occurrence of adverse events
Time frame: 3 month
Compare the number of adverse events and serious adverse events, the number of cases and the incidence rate; list the number and cases of adverse events; describe the adverse events that are related to the investigational products.
1 secondary outcome
BCVA (spectacles) and BCVA (CL)
Time frame: 1 week, 1 month, 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 6 Mar 2020.
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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.
Li Lihua, MD principal investigator
Tianjin Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contact Lenses in people with Myopia, run by Menicon Co., Ltd. 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 6 inclusion and 13 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 6 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 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?
The ratio of corrected visual acuity of left and right eyes is ≥5.0 (time frame: 1 week). 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 6 Mar 2020.