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

ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-24
SponsorKubota Vision Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • KG1
  • KG2
  • KG3
  • KG4
  • KG5

Treatment groups

35 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators