| Registry | NCT05733884 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 100 (Actual) |
| Sponsor | Chung Shan Medical University (Other) |
| Conditions | Soft Contact Lens |
| Interventions | soft contact lens (Other) |
| Dates | start 2020-12-09, primary completion 2022-05-04, completion 2022-05-04, first posted 2023-02-17, last updated 2023-02-21 |
| Locations | 1 site in Taiwan |
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All trials for Soft Contact Lens All trials of soft contact lens
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Daily Disposable Multifocal Soft Contact lenses, PEGAVISION, Taiwan | Experimental | Other: soft contact lens | 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. |
| Omafilcon A, dual-focus optical design, USA | Active comparator | Other: soft contact lens | 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. |
Sex: All, ages: 8 Years to 15 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Chung Shan Medical University Hospital | Taichung | Taiwan |