NCT03761758

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

November 29, 2018

Last Update Submit

November 30, 2018

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

  • Distance Visual Acuity

    Measurement of best corrected distance visual acuity

    2 weeks

  • Contrast Sensitivity

    Measurement of contrast sensitivity

    2 weeks

  • Subjective Responses

    Assessment of subject responses related to wear time of spectacles

    2 weeks

Study Arms (3)

Lens Design 1

EXPERIMENTAL

Spectacle lenses design 1, fitted into spectacle frames

Device: Spectacle lenses

Lens Design 2

EXPERIMENTAL

Spectacle lenses design 2, fitted into spectacle frames

Device: Spectacle lenses

Lens Design 3

EXPERIMENTAL

Spectacle lenses design 3, fitted into spectacle frames

Device: Spectacle lenses

Interventions

Spectacle lensesDEVICE

Spectacle lenses with clear central apertures

Lens Design 1Lens Design 2Lens Design 3

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages between 6 and 12 years
  • Myopia between -1.00 and -4.00 D

You may not qualify if:

  • Participating in any clinical or other research study
  • Contact lens wearer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Joe Rappon, OD, MS

    SightGlass Vision

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2018

First Posted

December 3, 2018

Study Start

May 1, 2018

Primary Completion

July 19, 2018

Study Completion

July 19, 2018

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)