Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults

NCT06528860 | Not Yet Recruiting

• 1 other identifier: QX-2024-A-002
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.

Conditions

Myopia

Keywords

Myopia; Dual-focus contact lenses; Young adults; Adult myopia progression

Outcome Measures

Primary Outcomes (1)

• Change in cycloplegic spherical equivalent after 2 years

  The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.

  2 years after the baseline

Secondary Outcomes (1)

• Change in axial length after 2 years

  2 years after the baseline

Study Arms (2)

Dual-focus CL

EXPERIMENTAL

Wearing dual-focus CL for 2 years

Device: MiSight® 1 day soft contact lenses

Single-vision CL

PLACEBO COMPARATOR

Wearing single-vision CL for 2 years

Device: Proclear® 1 day soft contact lenses

Interventions

MiSight® 1 day soft contact lenses DEVICE

Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.

Also known as: CooperVision

Dual-focus CL

Proclear® 1 day soft contact lenses DEVICE

Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.

Also known as: CooperVision

Single-vision CL

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-25 years;
• Myopia progression \<= -0.50D in either eye in the past year (evaluated by -manifest refraction);
• The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;
• The subject eye's best corrected visual acuity \<= logMAR 0.1;
• Anisometropia does not exceed 1.50D.

You may not qualify if:

• Current use of MC interventions or prior use of MC interventions within the past 6 months;
• Disease or anatomical factors that affect the wearing of contact lenses;
• History of myopia correction surgery;
• Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;
• pregnant female;
• Other conditions deemed unsuitable by the investigators.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200041, China

Location

Related Publications (2)

• Ruiz-Pomeda A, Villa-Collar C. Slowing the Progression of Myopia in Children with the MiSight Contact Lens: A Narrative Review of the Evidence. Ophthalmol Ther. 2020 Dec;9(4):783-795. doi: 10.1007/s40123-020-00298-y. Epub 2020 Sep 11.

  PMID: 32915454 BACKGROUND

• Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2.

  PMID: 37126362 BACKGROUND

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Xiangui He

  Shanghai Eye Disease Prevention & Treatment Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangui He

CONTACT

(86)15000755422; xianhezi@163.com

Hotin Wu

CONTACT

(86)19821287621; 24499980@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This study will utilize a Central Randomization System (CRS) for the random grouping and glasses allocation of study subjects during the clinical trial. Investigators and participants will be blinded to the intervention received until unblinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention Group: Daily disposable bifocal soft corneal contact lenses: MiSight® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%). Control Group: Daily disposable single-focus soft corneal contact lenses: Proclear® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%)

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 30, 2024
• Study Start: August 31, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)