WALNUT: Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

Sponsor

SightGlass Vision, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03761758

Collaborator

(none)

Enrollment

Location

Arms

2.6

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Spectacle lenses	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Device Feasibility

Official Title:

Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Jul 19, 2018

Actual Study Completion Date :

Jul 19, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Distance Visual Acuity [2 weeks]
Measurement of best corrected distance visual acuity
Contrast Sensitivity [2 weeks]
Measurement of contrast sensitivity
Subjective Responses [2 weeks]
Assessment of subject responses related to wear time of spectacles

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Ocular Research & Education	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

SightGlass Vision, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SightGlass Vision, Inc.

ClinicalTrials.gov Identifier:

NCT03761758

Other Study ID Numbers:

P/639/18/SG

First Posted:

Dec 3, 2018

Last Update Posted:

Dec 3, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Dec 3, 2018