AmblyopiaNCT02782117
Luminopia One Pilot Study
A study testing Luminopia One in people with Amblyopia, run by Luminopia at 9 sites in United States.
Trial summary
A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Luminopia One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Aug 2017to 6 Feb 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Major Eligibility Criteria:
- Age 4 to <8 years (phase 1) or age 4 to <13 years (phase 2)
- Monocular amblyopia associated with anisometropia, strabismus or both combined
- Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR)
- Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2)
- Interocular BCVA difference ≥3 lines (≥0.3 logMAR)
- Visual acuity stability in current refractive correction (phase 2)
- Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Indiana University
Bloomington, Indiana, 47405
Wheaton Eye Clinic
Chicago, Illinois, 60187
Concord Eye Center
Concord, New Hampshire, 03301
Children's Eye Care of Michigan
Dearborn, Michigan, 48124
Kids Eye Care of Maryland
Frederick, Maryland, 21703
Houston Eye Associates
Houston, Texas, 77025
Conestoga Eye
Lancaster, Pennsylvania, 17601
Eye Physicians of Central Florida
Maitland, Florida, 32751
Virginia Pediatric Eye Center
Virginia Beach, Virginia, 23452
About this study
A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.
- Conditions
- Amblyopia
- Being tested
- Luminopia One
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luminopia OneDevice
Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Regimen A | Experimental | Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks. Receives: Device: Luminopia One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amblyopic eye best-corrected visual acuity
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Measured: 12 weeks
Secondary outcomes (3)
Amblyopic eye best-corrected visual acuity
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Measured: 8 weeks
Amblyopic eye best-corrected visual acuity
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Measured: 4 weeks
Adherence
Duration spent using the device divided by duration of treatment prescribed (objectively monitored)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start1 Aug 2017
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luminopia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- David Hunter, MD PhD, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782117
- Sponsor's protocol ID
- C-AM-1C AND C-AM-1D
- Status last verified
- Jul 2020
- First submitted
- 19 May 2016
- Last updated
- 9 Jul 2020
- 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 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luminopia One Pilot Study
- ClinicalTrials.gov ID
- NCT02782117
- Acronym / sponsor ID
- C-AM-1C AND C-AM-1D
- Conditions
- Amblyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- LuminopiaIndustry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 25 May 2016 (estimated)
- 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 single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.
| Arm | Type | Receives |
|---|---|---|
| Treatment Regimen A | Experimental | Device: Luminopia OneTreatment Regimen A will use the Luminopia device for an hour per day for 12 weeks. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Luminopia OneLuminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied. | Device | Treatment Regimen A |
Primary outcome
Amblyopic eye best-corrected visual acuity
Time frame: 12 weeks
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
3 secondary outcomes
Amblyopic eye best-corrected visual acuity
Time frame: 8 weeks
Amblyopic eye best-corrected visual acuity
Time frame: 4 weeks
Adherence
Time frame: 12 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 9 Jul 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.
David Hunter, MD PhD study director
Boston Children's Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luminopia One in people with Amblyopia, run by Luminopia at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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?
Amblyopic eye best-corrected visual acuity (time frame: 12 weeks). 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 9 Jul 2020.