Myopia Control Using Novel Soft Contact Lenses
ConditionMyopia
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- Lens A
- Lens B
Treatment groups
126 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
The Hong Kong Polytechnic University
Lead sponsor
Eyebright Medical Technology (Beijing) Co., Ltd.
Collaborator
Source ClinicalTrials.gov