A trial to assess the short-term efficacy of spectacle films and contact lenses in myopic childre
- Conditions
- MyopiaEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12623000319673
- Lead Sponsor
- nthalmic Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Aged between 7-15 years inclusive
Have read, understood and signed informed assent
Parents have read, understood and signed informed consent
Adhere to study requirements, wear study products and maintain visit schedule
Have good general health and normal ocular health
Best-corrected high contrast visual acuity of 6/7.6 or better in each eye
If wearing spectacle study product: Spectacle refraction of:
-sphere component between -0.50DS and -4.00DS inclusive and spherical equivalent less than or equal to -0.75D
-Astigmatic correction between 0DC and -1.50DC inclusive
If wearing contact lens study product: Spectacle refraction of:
-sphere component less than or equal to -0.50D and spherical equivalent between -0.75D and -4.00D inclusive
-Astigmatic correction between 0DC and -1.00DC inclusive
Current or use within 12 months of myopia management options including but not limited to
-Bifocal/multifocal spectacles or contact lenses
-Orthokeratology
-Atropine/pirenzepine pharmacological agents
If contact lenses are the chosen study product: contraindications to contact lens wear, including any pre-existing ocular irritation, injury, or condition (including infection or disease) of the cornea, conjunctiva or eyelids
Any systemic disease that adversely affects ocular health e.g., diabetes, Graves’ disease, and auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
Use of or a need for concurrent category S3 and above ocular medication at enrolment.
Eye surgery within 12 weeks immediately prior to enrolment for this trial.
Keratoconus
Manifest strabismus
Known allergy or intolerance to ingredients in any of the clinical trial products.
Currently enrolled in another clinical trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method