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The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.
The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Group | Experimental | Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks. |
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| Control Group | Active Comparator | Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luminopia One | Device | Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia. |
| Measure | Description | Time Frame |
|---|---|---|
| Best-Corrected Visual Acuity of Amblyopic Eye | Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol. | 12 weeks |
| Best-Corrected Visual Acuity of Fellow Eye | Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Mean adherence with the therapeutic in treatment group. | 12 weeks |
| Best-Corrected Visual Acuity of Amblyopic Eye | Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Xiao | Luminopia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Jules Stein Eye Institute | Los Angeles | California | 90095 | United States | ||
| Family Focus Eye Care |
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapeutic Group | Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks. Luminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2018 | May 12, 2020 |
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| Refractive Correction | Device | Standard of care refractive correction (ex. spectacles) |
|
| 4 weeks |
| Best-Corrected Visual Acuity of Amblyopic Eye | Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol. | 8 weeks |
| Stereoacuity | Mean stereoacuity improvement from baseline after 12 weeks. | 12 weeks |
| Gainesville |
| Florida |
| 32605 |
| United States |
| Eye Physicians of Central Florida | Maitland | Florida | 32751 | United States |
| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
| IU School of Optometry | Bloomington | Indiana | 47405 | United States |
| Kids Eye Care of Maryland | Frederick | Maryland | 21703 | United States |
| Specialized Pediatric Eye Care | Beverly | Massachusetts | 01915 | United States |
| Children's Eye Care of Michigan | Dearborn | Michigan | 48124 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Duke University | Durham | North Carolina | 27708 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| OSU College of Optometry | Columbus | Ohio | 43210 | United States |
| Pediatric Ophthalmology of Erie | Erie | Pennsylvania | 16501 | United States |
| Conestoga Eye | Lancaster | Pennsylvania | 17601 | United States |
| Children's Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Tri-County Eye Physicians | Southampton | Pennsylvania | 18966 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Texas Children's Hospital (BCM) | Houston | Texas | 77030 | United States |
| Houston Eye Associates | Houston | Texas | 77381 | United States |
| Rocky Mountain Eye Care | Salt Lake City | Utah | 84107 | United States |
| Virginia Pediatric Eye Center | Virginia Beach | Virginia | 23452 | United States |
| FG001 |
| Control Group |
Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks. Refractive Correction: Standard of care refractive correction (ex. spectacles) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapeutic Group | Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks. Luminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia. |
| BG001 | Control Group | Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks. Refractive Correction: Standard of care refractive correction (ex. spectacles) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Prior Amblyopia Treatment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Best-Corrected Visual Acuity of Amblyopic Eye | Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol. | Posted | Mean | Standard Deviation | Lines of visual acuity improvement | 12 weeks |
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| Primary | Best-Corrected Visual Acuity of Fellow Eye | Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol. | Posted | Mean | Standard Deviation | Lines of visual acuity improvement | 12 weeks |
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| Secondary | Adherence | Mean adherence with the therapeutic in treatment group. | Posted | Median | Inter-Quartile Range | percentage of prescribed therapy | 12 weeks |
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| Secondary | Best-Corrected Visual Acuity of Amblyopic Eye | Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol. | Posted | Mean | Standard Deviation | Lines of visual acuity improvement | 4 weeks |
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| Secondary | Best-Corrected Visual Acuity of Amblyopic Eye | Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol. | Posted | Mean | Standard Deviation | Lines of visual acuity improvement | 8 weeks |
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| Secondary | Stereoacuity | Mean stereoacuity improvement from baseline after 12 weeks. | Posted | Mean | Standard Deviation | Change in log arc seconds | 12 weeks |
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Adverse event data were collected throughout the study at each follow-up phone call or visit.
Serious and Mortality adverse events are reported for all consented individuals. Non-serious adverse events are reported for all participants in the study according to the As Treated Population. i.e. participants actually using the investigational product or the control group product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Therapeutic Group | Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks. Luminopia One: Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia. | 0 | 58 | 0 | 58 | 13 | 51 |
| EG001 | Control Group | Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks. Refractive Correction: Standard of care refractive correction (ex. spectacles) | 0 | 59 | 0 | 59 | 9 | 59 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New heterotropia | Eye disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Worsening best-corrected visual acuity | Eye disorders | Systematic Assessment |
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We evaluated the therapeutic alongside continued refractive correction alone over 12 weeks and we did not compare with patching or atropine penalization, so we do not know the relative safety and efficacy of the therapeutic versus patching or atropine, nor the durability of benefit from the therapeutic. The duration of our study was limited to 12 weeks, which may have biased the results toward superiority of one treatment over the other depending on the time course of responses.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Clinical Development | Luminopia, Inc. | 9788067080 | endri@luminopia.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 9, 2020 | Sep 2, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000550 | Amblyopia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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