Myopia Control Using Novel Soft Contact Lenses

ConditionMyopia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age7-12

SponsorThe Hong Kong Polytechnic University

About this trial

The goal of this study is to investigate the myopic control efficacy of two study soft contact lenses in children. Participants will be prescribed Lens A, Lens B or single vision contact lenses for the first year. Participants in single vision contact lenses group will switch to Lens A at 12 months. All participants will then continue lens wear for an additional 12 months. Their cycloplegic refraction and axial length will be monitored every 6 months for 2 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Age at enrolment: 7 - 12 (both inclusive) years old Hong Kong Chinese schoolchildren

Refractive errors in terms of spherical equivalent refraction (SER) determined by cycloplegic autorefraction: -0.75 diopters (D) to -5.00D in both eyes

Astigmatism: equal or less than -1.00D

Anisometropia: equal or less than -1.75D

Disqualifiers

Contraindications for soft contact lenses

Dry eye with drug intervention within 30 days

Regular use of ocular medication (prescription or over-the-counter), artificial tears, or wetting agents due to dryness, allergies or other conditions that hinder the contact lens wear

Current use of systemic medications that may significantly affect contact lens wear, tear film production, pupil size, accommodation, or refractive state. These include, but not limited to, long term use of nasal decongestants (e.g., pseudoephedrine, phenylephrine), antihistamines (e.g., chlorpheniramine, diphenhydramine, Prednisolone or Ritalin (methylphenidate)

Trial design

Design model

Parallel

Treatments tested in this trial

Lens A
Other intervention
Lens A contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus.
Lens B
Other intervention
Lens B contact lens is a daily disposable silicon hydrogel contact lenses with peripheral myopic defocus.

Treatment groups

126 Participants

are divided into 3 treatment groups

Group A: Single vision lens groupNo intervention 0 interventions

Group B: Lens A groupExperimental treatment 1 intervention

Group C: Lens B groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Cycloplegic refraction change in spherical equivalent refraction (SER)

Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline every 6 months for 2 years over the study period.

Time frame

Baseline, 6, 12, 18 and 24 months

Secondary outcomes

Axial length changes

Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline every 6 months for 2 year over the study period.

Time frame

Baseline, 6, 12, 18 and 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hong Kong Polytechnic University

Lead sponsor

Eyebright Medical Technology (Beijing) Co., Ltd.

Collaborator

Source ClinicalTrials.gov

Apply now