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

NCT ID: NCT05733884

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2022-05-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

soft contact lens

Intervention Type: OTHER

soft contact lens

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.

Group Type: ACTIVE_COMPARATOR

soft contact lens

Intervention Type: OTHER

soft contact lens

Interventions

soft contact lens

soft contact lens

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min yen Hsu, PhD

Role: STUDY_DIRECTOR

Chung Shan Medical University

Locations

Chung Shan Medical University Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CS1-20136

Identifier Type: -

Identifier Source: org_study_id