A Controlled Evaluation of Optical Defocus Parameters on Transient Changes in Axial Length Using Kubota Glass

June 30, 2026 updated by: Kubota Vision Inc.
This study will assess the optimal performance characteristics of optical defocus on transient changes in axial length with Kubota Glass, using a randomized, double-masked, 5-treatment, 5-period crossover design with contralateral eye control.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

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 Contact

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
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
  • Sign written Informed Consent (and the California Bill of Rights, if applicable).
  • Be between age 8-24 (inclusive) and able to understand and assent to participation.
  • Have a spherical component of spectacle prescription between -1.00 and -5.00 diopters (D) (inclusive) in each eye.
  • Have a refractive astigmatism of less than or equal to -1.00 D in each eye.
  • Have axial length between 23.00 and 25.99 millimeters (mm) in each eye.
  • Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better in each eye.
  • Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion Criteria:

  • Unable or unwilling to provide informed consent and assent.
  • Eye injury or surgery within twelve weeks immediately prior to enrollment.
  • Currently enrolled in an ophthalmic clinical trial.
  • Pregnant or lactating or expect to become pregnant during the trial (by self-report).
  • Evidence of systemic or ocular abnormality, infection or disease.
  • Use of medications that may affect the eye (including, but not limited to, corticosteroids and antimetabolites).
  • Anisometropia ≥ 2.00.
  • Subjects who have undergone corneal refractive surgery.
  • Use atropine or other anticholinergic drug within the past month.
  • Employees or immediate family members of employees of study sites or sponsor.

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 2
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 3
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 4
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 5
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 6
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 7
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 8
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 9
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter
Experimental: Sequence 10
Device: KG1
Unique Kubota Glass optical defocus parameter
Device: KG2
Unique Kubota Glass optical defocus parameter
Device: KG3
Unique Kubota Glass optical defocus parameter
Device: KG4
Unique Kubota Glass optical defocus parameter
Device: KG5
Unique Kubota Glass optical defocus parameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Axial length
Time Frame: 1 hour
1 hour

Collaborators and Investigators

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

Sponsor

Kubota Vision Inc.

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 (Estimated)

July 6, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

June 30, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

June 30, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KV-JAX-RCT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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