Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Not Applicable

Recruiting

• Conditions: Myopia
• Interventions: Device: Multifocal contact lenses; Device: Single vision contact lenses

• Registration Number: NCT05159765
• Lead Sponsor: Visioneering Technologies, Inc

Brief Summary

This is a multi-center, randomized, double-masked clinical trial. All study devices are market approved/cleared in the localities where the study is conducted. Subjects will be randomly assigned to wear NaturalVue Sphere single vision contact lenses (SVCL) or NaturalVue Multifocal (NVMF) soft contact lenses for a total of three years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Study First Posted: 2021-12-16
• Study Start: 2022-01-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-06
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1. Male or female, aged 7 to <13 (inclusive) at the Screening/Baseline examination.

2. Meet the following refractive criteria determined by cycloplegic autorefraction at Screening/Baseline:

   • Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 D inclusive.
   • Astigmatism: ≤ -0.75 D
   • Anisometropia: < 1.000

Exclusion Criteria

1. Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
2. Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
3. Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
4. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
5. The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Multifocal contact lenses	Contact lens with refractive correction, multifocal optic
Control	Single vision contact lenses	Contact lens with refractive correction, single vision optic

Primary Outcome Measures

Name	Time	Method
Change in Refractive Error relative to Baseline	Baseline, 12, 24, 36 months	Mean change in cycloplegic auto-refraction (D)

Secondary Outcome Measures

Name	Time	Method
Change in Axial Length	Baseline,12, 24, 36 months	Mean change in Axial Length (mm)

Trial Locations

Locations (8)

Myopia Specialist Centre; 🇸🇬 Singapore, Singapore

Fig Garden Optometry; 🇺🇸 Fresno, California, United States

Toronto Eye Care; 🇨🇦 Toronto, Ontario, Canada

North Suburban Vision Consultants; 🇺🇸 Deerfield, Illinois, United States

Cooper Eye Care; 🇺🇸 New York, New York, United States

Bellaire Family Eye Care; 🇺🇸 Bellaire, Texas, United States

University of Waterloo School of Optometry; 🇨🇦 Waterloo, Ontario, Canada

Hong Kong Polytechnic University; 🇭🇰 Tsim Sha Tsui, Hong Kong