Soft Peripheral Contact Lens for Eye Elongation Control (SPACE):1-year Results of a Double-blinded Randomized Con-trolled Trial

NCT05733884 | Completed

• 1 other identifier: CS1-20136
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, randomised, double-blinded clinical trial was conducted including 115 children (55 male and 60 female) aged 8 to 15 years. The newest multifocal contact lenses were assigned to experimental group, and another commercial dual-focus optical designed contact lenses were assigned to control group to be worn for at least 8 hours per day, 7 days a week, for a period of 1 year. All contact lenses were replaced with new lenses every day. Measurements obtained using a LogMAR vision meter, including automated computerised optometry, handheld retinoscopy, high (96%) and low (12%) contrast sensitivity visual acuity values at a distance, and near-visible acuity values were used to evaluate the corneal curvature using a corneal mapper. Additionally, the axial length(AXL) of the eye was measured, and the tear quality was assessed using a slit lamp, including tear break-up time, tear river height, and observation of blink frequency. Furthermore, the eye's anterior surface was examined by slit lamp using the Efron grading scale.

Conditions

Soft Contact Lens

Keywords

axial length; children; myopia control; soft contact lens; clinical trials

Outcome Measures

Primary Outcomes (1)

• Spherical Equivalent Refraction (SER)

  The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.

  12 months

Secondary Outcomes (1)

• Axial Eye Length (AXL)

  12 months

Other Outcomes (1)

• Primary safety Endpoints

  12 months

Study Arms (2)

Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan

EXPERIMENTAL

Subjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months.

Other: soft contact lens

Omafilcon A, dual-focus optical design, USA

ACTIVE COMPARATOR

Subjects will be asked to wear the lenses for 8 hours a day, at least 7 days a week. Contact lenses are worn and replaced every day. All subjects will be followed for 1 year after device allocation and will undergo brief clinical assessments at 1 day, 1 week, 1, 3, 6, 9, and 12 months.

Other: soft contact lens

Interventions

soft contact lens OTHER

soft contact lens

Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan; Omafilcon A, dual-focus optical design, USA

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects must be between the ages of 8 and 15 (both 8 and 15 years old).
• Subject's best corrected visual acuity must be at least LogMAR 0.10 or higher in both eyes.
• The subject's eyes must be healthy and normal, and "normal eyes" is defined as having the following characteristics.
• Based on the slit-lamp examination results of the screening clinic, determined that the infection of the conjunctiva, eyelids and accessory organs was less than Grade 2 (mild).
• No structural abnormality of the eyelid, conjunctiva or accessory organ tissue.
• Slit lamp findings must be less than Grade 1 (mild) and the cornea must not show: edema, staining, clouding, or vascularization according to the slit lamp findings of the screening clinic.
• No iritis.
• There are no other active eye diseases that are not suitable for contact lens wear.
• No topical eye drops are currently being used.
• The subject and his/her legal representative (if the subject is under 20 years old) are willing to sign the subject's consent form.
• Legal guardians of subjects under 12 years of age are willing to sign the informed consent form.
• Meet the following refractive criteria determined by cycloplegic autorefraction at baseline
• Spherical equivalent refractive error: between -0.75 and -6.00 D inclusive
• Astigmatism: ≤-0.75 D
• Anisometropia: \<1.00 D

You may not qualify if:

• Participants with certain eye diseases that may affect their eye health or may be aggravated by the test product.
• Those who are unable to comply with regular tracking and inspection.
• Subject is currently participating, or has participated in another drug trial within 4 weeks prior to enrollment in this trial.
• Subject has undergone any eye surgery or corneal surgery.
• Subject has used systemic steroids, other systemic medications that may significantly affect vision or recovery, ophthalmic steroids, eye ointments, or pupil dilators (except for examination pupil dilators) within 2 weeks prior to trial entry.
• Those who are unable to cooperate with regular tracking and inspection.
• Participants with poor hygiene practices that may compromise safety during the trial or be inconsistent with the participant's best interests.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

MeSH Terms

Interventions

Contact Lenses, Hydrophilic

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Min yen Hsu, PhD

  Chung Shan Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 17, 2023
• Study Start: December 9, 2020
• Primary Completion: May 4, 2022
• Study Completion: May 4, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)