Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast (WALNUT)

November 30, 2018 updated by: SightGlass Vision, Inc.
Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • Centre for Ocular Research & Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lens Design 1
Spectacle lenses design 1, fitted into spectacle frames
Device: Spectacle lenses
Spectacle lenses with clear central apertures
EXPERIMENTAL: Lens Design 2
Spectacle lenses design 2, fitted into spectacle frames
Device: Spectacle lenses
Spectacle lenses with clear central apertures
EXPERIMENTAL: Lens Design 3
Spectacle lenses design 3, fitted into spectacle frames
Device: Spectacle lenses
Spectacle lenses with clear central apertures

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SightGlass Vision, Inc.

Investigators

  • Study Director: Joe Rappon, OD, MS, SightGlass Vision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ACTUAL)

July 19, 2018

Study Completion (ACTUAL)

July 19, 2018

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

November 30, 2018

First Posted (ACTUAL)

December 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/639/18/SG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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