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NCT03761758 Clinical Trial

Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

Myopia Clinical Trial

— WALNUT  

Official title:
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03761758
Other study ID # P/639/18/SG
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2018
Est. completion date July 19, 2018

Study information
Verified date November 2018
Source SightGlass Vision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date July 19, 2018
Est. primary completion date July 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- Ages between 6 and 12 years

- Myopia between -1.00 and -4.00 D

Exclusion Criteria:

- Participating in any clinical or other research study

- Contact lens wearer

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Spectacle lenses
Spectacle lenses with clear central apertures

Locations
Country Name City State
Canada Centre for Ocular Research & Education Waterloo Ontario

Sponsors (1)
Lead Sponsor Collaborator
SightGlass Vision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Distance Visual Acuity Measurement of best corrected distance visual acuity 2 weeks
Primary Contrast Sensitivity Measurement of contrast sensitivity 2 weeks
Primary Subjective Responses Assessment of subject responses related to wear time of spectacles 2 weeks
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