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

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.

Study Overview

• Status: Completed
• Conditions: Soft Contact Lens
• Intervention / Treatment: Other: soft contact lens

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

  1. 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).
  2. No structural abnormality of the eyelid, conjunctiva or accessory organ tissue.
  3. 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.
  4. No iritis.
  5. 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

  1. Spherical equivalent refractive error: between -0.75 and -6.00 D inclusive
  2. Astigmatism: ≤-0.75 D
  3. Anisometropia: <1.00 D

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan; 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; soft contact lens
Active Comparator: Omafilcon A, dual-focus optical design, USA; 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; soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spherical Equivalent Refraction (SER)	The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial Eye Length (AXL)	The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety Endpoints	All dispensed eyes over all follow-up visits. Measured on a scale of 0-4 with 0=no findings and 4=severe findings. Epithelial edema, epithelial microcysts, corneal staining, limbal & bulbar injection, conjunctival abnormalities, corneal neovascularization and infiltrates will be measured.(700GL Slit Lamp, Takagi Europe)	12 months

Collaborators and Investigators

• Sponsor: Chung Shan Medical University
• Investigators: Study Director: Min yen Hsu, PhD, Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2020
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: children; clinical trials; soft contact lens; axial length; myopia control
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CS1-20136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No