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Trial record 1 of 2 for:    luminopia
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Luminopia One Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02782117
Recruitment Status : Completed
First Posted : May 25, 2016
Last Update Posted : July 9, 2020
Sponsor:
Collaborator:
Boston Children's Hospital
Information provided by (Responsible Party):
Luminopia

Tracking Information
First Submitted Date  ICMJE May 19, 2016
First Posted Date  ICMJE May 25, 2016
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date February 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2019)
  • Amblyopic eye best-corrected visual acuity [ Time Frame: 8 weeks ]
    Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
  • Amblyopic eye best-corrected visual acuity [ Time Frame: 4 weeks ]
    Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
  • Adherence [ Time Frame: 12 weeks ]
    Duration spent using the device divided by duration of treatment prescribed (objectively monitored)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Luminopia One Pilot Study
Official Title  ICMJE Luminopia One Pilot Study
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Amblyopia
Intervention  ICMJE Device: Luminopia One
Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.
Study Arms  ICMJE Experimental: Treatment Regimen A
Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.
Intervention: Device: Luminopia One
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2019)
84
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 6, 2019
Actual Primary Completion Date February 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02782117
Other Study ID Numbers  ICMJE C-AM-1C AND C-AM-1D
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Luminopia
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Luminopia
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Boston Children's Hospital
Investigators  ICMJE
Study Director: David Hunter, MD PhD Boston Children's Hospital
PRS Account Luminopia
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP