MyopiaWALNUTNCT03761758
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
A study testing Spectacle lenses in people with Myopia, run by SightGlass Vision, Inc. at 1 site in Canada.
Trial summary
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2018to 19 Jul 2018
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages between 6 and 12 years
- Myopia between -1.00 and -4.00 D
Who cannot join
- Participating in any clinical or other research study
- Contact lens wearer
Trial locations and contacts
1 site in 1 country.
About this study
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.
Read the detailed description
This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.
- Conditions
- Myopia
- Being tested
- Spectacle lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectacle lensesDevice
Spectacle lenses with clear central apertures
| Study group | Role | What they receive |
|---|---|---|
| Lens Design 1 | Experimental | Spectacle lenses design 1, fitted into spectacle frames Receives: Device: Spectacle lenses |
| Lens Design 2 | Experimental | Spectacle lenses design 2, fitted into spectacle frames Receives: Device: Spectacle lenses |
| Lens Design 3 | Experimental | Spectacle lenses design 3, fitted into spectacle frames Receives: Device: Spectacle lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity
Measurement of best corrected distance visual acuity
Measured: 2 weeks
Contrast Sensitivity
Measurement of contrast sensitivity
Measured: 2 weeks
Subjective Responses
Assessment of subject responses related to wear time of spectacles
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start1 May 2018
- Primary completion19 Jul 2018
- Study completion19 Jul 2018
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.
- More trials run by SightGlass Vision, Inc.The sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- SightGlass Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Rappon, OD, MS, Study director, SightGlass Vision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761758
- Sponsor's protocol ID
- P/639/18/SG
- Acronym
- WALNUT
- Status last verified
- Nov 2018
- First submitted
- 29 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
- ClinicalTrials.gov ID
- NCT03761758
- Acronym / sponsor ID
- WALNUT / P/639/18/SG
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- SightGlass Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 3 Dec 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.
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.
Detailed description
This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lens Design 1 | Experimental | Device: Spectacle lensesSpectacle lenses design 1, fitted into spectacle frames |
| Lens Design 2 | Experimental | Device: Spectacle lensesSpectacle lenses design 2, fitted into spectacle frames |
| Lens Design 3 | Experimental | Device: Spectacle lensesSpectacle lenses design 3, fitted into spectacle frames |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Ages between 6 and 12 years
- Myopia between -1.00 and -4.00 D
Key exclusion criteria (2 listed)
- Participating in any clinical or other research study
- Contact lens wearer
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 |
|---|---|---|
| Spectacle lensesSpectacle lenses with clear central apertures | Device | Lens Design 1, Lens Design 2, Lens Design 3 |
Primary outcome
Distance Visual Acuity
Time frame: 2 weeks
Measurement of best corrected distance visual acuity
Contrast Sensitivity
Time frame: 2 weeks
Measurement of contrast sensitivity
Subjective Responses
Time frame: 2 weeks
Assessment of subject responses related to wear time of spectacles
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 3 Dec 2018.
- 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.
Joe Rappon, OD, MS study director
SightGlass Vision
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectacle lenses in people with Myopia, run by SightGlass Vision, Inc. at 1 site in Canada.
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 2 inclusion and 2 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 3 Dec 2018. 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 Canada. 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?
Distance Visual Acuity (time frame: 2 weeks). The study lists 3 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 3 Dec 2018.