Customizing Myopia Control With Multifocal Toric Contact Lens

NCT04352868 | Withdrawn FDA Device

• 1 other identifier: IRB-300004596
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism.

Conditions

Refractive Errors; Myopia

Keywords

Myopia; Multifocal contact lens; Refractive error; Myopia treatment; Myopia control; Myopia management

Outcome Measures

Primary Outcomes (2)

• Refractive error progression

  Refractive error measured by cycloplegic autorefraction in both eyes, will be measured at baseline and at one year to assess the difference in spherical component of the refractive error between the treatment group (multifocal toric soft contact lens) and the control group (toric soft contact lens)

  1 years

• Axial length

  Change in axial length as measured by non-contact axial length both eyes, will be measured at baseline and at one year to assess the difference in change in axial length between the treatment group (multifocal toric soft contact lens) and the control group (toric soft contact lens)

  1 years

Study Arms (2)

Toric soft contact lens

ACTIVE COMPARATOR

Toric soft contact lens

Device: Intelliwave toric, soft contact lens

Multifocal toric soft contact lens

EXPERIMENTAL

A multifocal toric soft contact lens with a +2.00 D add.

Device: Intelliwave multifocal, toric, soft contact lens

Interventions

Intelliwave multifocal, toric, soft contact lens DEVICE

This is a quarterly disposable, multifocal, toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

Multifocal toric soft contact lens

Intelliwave toric, soft contact lens DEVICE

This is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

Toric soft contact lens

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 12 years, inclusive, at baseline examination
• to -6.00 D, inclusive, spherical component, cycloplegic autorefraction
• ≥0.75 DC, cycloplegic autorefraction
• logMAR or better best-corrected visual acuity in each eye

You may not qualify if:

• Eye disease or refractive error conditions (e.g., keratoconus, retinal abnormalities, retinopathy of prematurity, etc.)
• Ocular surgery, severe ocular trauma, active ocular infection or inflammation
• Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Refractive Errors; Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Andrew D Pucker, OD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share