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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04784390




Registration number
NCT04784390
Ethics application status
Date submitted
2/03/2021
Date registered
5/03/2021
Date last updated
23/05/2023

Titles & IDs
Public title
Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia
Scientific title
A 16 Week Randomized, Single-masked, Multicenter Proof of Concept Study of Binocular Videogames Versus Patching for Amblyopia in Children 4-7 Years of Age With an Open-label Substudy of Binocular Videogames in Children 8-12 Years of Age
Secondary ID [1] 0 0
CDDO001F12201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Amblyopia 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Binocular video games
Treatment: Devices - Patching of the sound eye

Active comparator: Patching - Patching of the sound eye (fellow eye) - patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.

Experimental: Binocular video games - Binocular video games - patients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks.


Treatment: Devices: Binocular video games
Patients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks.

Treatment: Devices: Patching of the sound eye
Patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in best corrected visual acuity (BCVA) in the amblyopic eye.
Timepoint [1] 0 0
from Baseline to Week 8
Secondary outcome [1] 0 0
Attain BCVA of 0.1 logMAR or better in the amblyopic eye
Timepoint [1] 0 0
at Week 4, Week 8, Week 12, and Week 16.
Secondary outcome [2] 0 0
Change in stereoacuity or binocular video game relative to patching.
Timepoint [2] 0 0
from Baseline to Week 4, Week 8, Week 12, and Week 16.
Secondary outcome [3] 0 0
Attain a 2-line or better improvement in BCVA in the amblyopic eye
Timepoint [3] 0 0
at Week 4, Week 8, Week 12, and Week 16.
Secondary outcome [4] 0 0
Change in BCVA in the amblyopic eye
Timepoint [4] 0 0
from Baseline to Week 4, Week 12, and Week 16.
Secondary outcome [5] 0 0
Frequency of treatment-emergent Adverse Events
Timepoint [5] 0 0
from Baseline to week 16
Secondary outcome [6] 0 0
Time played as recorded in the diary
Timepoint [6] 0 0
from Baseline to week 12
Secondary outcome [7] 0 0
Time patched as recorded in the diary
Timepoint [7] 0 0
from Baseline to week 16
Secondary outcome [8] 0 0
Time played as recorded in the video game system
Timepoint [8] 0 0
from Baseline to week 12
Secondary outcome [9] 0 0
Percentage of participants who complete at least 75% of prescribed game play
Timepoint [9] 0 0
from Baseline to Week 12

Eligibility
Key inclusion criteria
1. Written informed consent must be signed by the parent(s) or legal guardian(s) prior to participation in the study.
2. Male or female children 4 to 7 years old at Screening (Part A) or 8 to 12 years old at Screening (Part B).
3. Diagnosis of amblyopia due to strabismus, anisometropia, or both.
4. Best corrected visual acuity (BCVA) of amblyopic eye (study eye) between 0.3 to 1.0 Logarithm of the Minimum Angle of Resolution (logMAR) (20/40 to 20/200 Snellen inclusive, 33 to 72 ETDRS letters inclusive) at Screening and Baseline.
5. BCVA of the sound eye (fellow eye) 0.1 logMAR (20/25 Snellen, 80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters) or better in children 5 years of age and older or 0.2 logMAR (20/30 Snellen, 75 ETDRS letters) or better in children 4 years of age at Screening and Baseline.
6. Interocular difference of BCVA at least 0.3 logMAR (=3 lines; ETDRS=15 letters) at Baseline.
7. Patient is able to play the binocular game (Dig Rush and Monster Burner) on at least level 3 on the study tablet under binocular conditions (with red-green glasses).
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment for amblyopia with patching, Bangerter filter, vision therapy, or binocular treatment in the past 1 week prior to Screening, or atropine in the past 4 weeks prior to Screening.
2. Treatment for amblyopia with patching, Bangerter filter, vision therapy, binocular treatment or atropine for more than 1 year prior to screening cumulatively.
3. Myopia = -6.00D spheric equivalent in either eye at Screening or Baseline.
4. Prior amblyopia treatment (patching, Bangerter filter, vision therapy, binocular treatment or atropine) for more than a year prior to screening cumulatively.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/08/2022
Sample size
Target
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novartis Investigative Site - North Ryde
Recruitment postcode(s) [1] 0 0
2109 - North Ryde
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Nevada
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this PoC study was to evaluate the potential therapeutic efficacy of binocular video games played on a tablet and to compare the efficacy of binocular video games versus patching in amblyopic patients 4 to 7 years old (Part A) as well as to gain experience with binocular video games in older children population of 8 to12 years old (Part B).

Part A and Part B was designed to provide long term data on durability of binocular video games treatment.

The study consisted of two parts, Part A: randomized, single masked PoC study in children 4 to 7 years old at Screening, and Part B: open-label substudy in children 8 to 12 year old at Screening.
Trial website
https://clinicaltrials.gov/study/NCT04784390
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04784390