Visual Performance of Highly Aspherical Lenslet Spectacles in Children (Ancillary to WS10246) (FIN-3102)

June 22, 2026 updated by: Essilor International

Clinical Evaluation of Vision Performance of the FIN C2 Lens

To evaluate the visual performance of (high and low contrast distance visual acuity, reading speed, near visual acuity, and near contrast sensitivity) of HAL spectacle lenses (habitual correction) in comparison with single vision control lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

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

  • United States
    • California
      • San Diego, California, United States, 92131
        • Scripps Poway Optometry
    • Florida
      • Longwood, Florida, United States, 32779
        • Sabal Eye Care
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Illinois College of Optometry
    • Kansas
      • Pittsburg, Kansas, United States, 66762
        • Kannarr Eye Care
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • New England College of Optometry
    • New York
      • New York, New York, United States, 10036
        • SUNY College of Optometry
      • Vestal, New York, United States, 13850
        • Sacco Eye Group

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Existing subjects from Essilor R&D Study WS10246 clinical study.
  • Ability to comply with study procedures.
  • Informed consent of parent/guardian and assent of subject.

Exclusion Criteria:

  • Current ocular infection, inflammation, or irritation likely to affect vision.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HAL spectacle lens
HAL spectacle lens using a innovative spectacle lens to control myopia progression
Device: HAL spectacle lens
HAL spectacle lens for myopia control
Placebo Comparator: Single vision spectacle lens
Single vision spectacle lens for myopia and astigmatism correction
Device: Single Vision spectacle lens
Single vision spectacle lens for myopia and astigmatism correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reading Speed
Time Frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Reading speed (mean words per minute) collected using the Wolffsohn Research iPad OptomCentral App
Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Binocular distance high contrast visual acuity (VA) through the lens periphery
Time Frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Measured to the nearest letter using a standard ETDRS chart at 4 meters.
Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Binocular photopic near contrast sensitivity function (CSF)
Time Frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Evaluated at 40 cm using the iPad OptomCentral App across various spatial frequencies to calculate the Area Under the Log Contrast Sensitivity Function (AULCSF).
Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.

Collaborators and Investigators

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

Sponsor

Essilor International

Collaborators

Visioncare Research Ltd.

Investigators

  • Study Director: Jason Shen, PhD, Essilor International, Affiliation of EssilorLuxottica

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 22, 2024

Primary Completion (Actual)

September 20, 2024

Study Completion (Actual)

October 20, 2024

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS10353

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.

No

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.

Clinical Trials on Myopia

Clinical Trials on HAL spectacle lens

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe