search
Back to results

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

Primary Purpose

Myopia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Spectacle lenses
Sponsored by
SightGlass Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Myopia

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre for Ocular Research & Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lens Design 1

Lens Design 2

Lens Design 3

Arm Description

Spectacle lenses design 1, fitted into spectacle frames

Spectacle lenses design 2, fitted into spectacle frames

Spectacle lenses design 3, fitted into spectacle frames

Outcomes

Primary Outcome Measures

Distance Visual Acuity
Measurement of best corrected distance visual acuity
Contrast Sensitivity
Measurement of contrast sensitivity
Subjective Responses
Assessment of subject responses related to wear time of spectacles

Secondary Outcome Measures

Full Information

First Posted
November 29, 2018
Last Updated
November 30, 2018
Sponsor
SightGlass Vision, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03761758
Brief Title
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
Acronym
WALNUT
Official Title
Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SightGlass Vision, Inc.

4. Oversight

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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lens Design 1
Arm Type
Experimental
Arm Description
Spectacle lenses design 1, fitted into spectacle frames
Arm Title
Lens Design 2
Arm Type
Experimental
Arm Description
Spectacle lenses design 2, fitted into spectacle frames
Arm Title
Lens Design 3
Arm Type
Experimental
Arm Description
Spectacle lenses design 3, fitted into spectacle frames
Intervention Type
Device
Intervention Name(s)
Spectacle lenses
Intervention Description
Spectacle lenses with clear central apertures
Primary Outcome Measure Information:
Title
Distance Visual Acuity
Description
Measurement of best corrected distance visual acuity
Time Frame
2 weeks
Title
Contrast Sensitivity
Description
Measurement of contrast sensitivity
Time Frame
2 weeks
Title
Subjective Responses
Description
Assessment of subject responses related to wear time of spectacles
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Rappon, OD, MS
Organizational Affiliation
SightGlass Vision
Official's Role
Study Director
Facility Information:
Facility Name
Centre for Ocular Research & Education
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

We'll reach out to this number within 24 hrs