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Clinical Trials/NCT03623074
NCT03623074
Active, not recruiting
Not Applicable

Efficacy and Safety Study of Novel Spectacle Lens Designs to Control of Myopia

SightGlass Vision, Inc.14 sites in 2 countries266 target enrollmentJuly 16, 2018
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ConditionsJuvenile Myopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Juvenile Myopia
Sponsor
SightGlass Vision, Inc.
Enrollment
266
Locations
14
Primary Endpoint
Spherical equivalent refraction
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

Registry
clinicaltrials.gov
Start Date
July 16, 2018
End Date
March 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent
  • •SER error between -0.75 and -4.50 D
  • •SER power between the two eyes must be less than or equal to 1.50 D
  • •Willingness to participate in the trial for 3 years without content lens wear

Exclusion Criteria

  • •Previous or current use of contact lenses
  • •Previous or current use of bifocals, progressive addition spectacles lenses
  • •Previous or current use of myopia control treatment
  • •Astigmatism worse then -1.25 DC in either eye

Outcomes

Primary Outcomes

Spherical equivalent refraction

Time Frame: 36 Months

Change in spherical equivalent refraction from baseline

Axial length

Time Frame: 36 Months

Change in axial length from baseline

Study Sites (14)

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