None listed
Conditions
Brief summary
There are two purposes to this trial. First, to assess the rate of change in axial length when wearing single vision contact lenses with an edge pattern against single vision contact lenses with no edge pattern. Second, to assess the rate of change in axial length when wearing single vision spectacle lenses with a spectacle film containing an edge pattern and adhered on top of the spectacle lens and single vision spectacle lenses with no spectacle film (i.e., no edge pattern). Axial length will be measured with a standard optical biometer. Contact lenses are made from ocufilcon D and spectacle films are made from polycarbonate. It is hypothesised that study products containing edge patterns will have a lower rate of change in axial length.
Interventions
This will be a prospective, randomised cross-over clinical trial. Participants will choose to either wear either study products (contact lenses or spectacles: i.e., a participant will wear one or the other, not both) for 14 months.
Contact lenses are made from ocufilcon D material and are replaced daily. A single vision contact lens will serve as the control, and a single vision contact lens with a tinted edge pattern will serve as the test. Contact lens wear will be contralateral, and the eye
This will be a prospective, randomised cross-over clinical trial. Participants will choose to either wear either study products (contact lenses or spectacles: i.e., a participant will wear one or the other, not both) for 14 months. Contact lenses are made from ocufilcon D material and are replaced daily. A single vision contact lens will serve as the control, and a single vision contact lens with a tinted edge pattern will serve as the test. Contact lens wear will be contralateral, and the eye first wearing the control or test will be randomly determined. Contact lenses will be worn for 6 months. A cross-over will occur at 6 months so that the eye wearing the control will wear the test, and the eye wearing the test will wear the control. Participants will wear contact lenses for a further 6 months. The minimum wear time for contact lenses will be 5 days per week and 6 hours per day to a maximum of 16 hours per day. The distance power of the contact lenses will be power matched to the participant’s myopic refractive error. At the conclusion of 12 months of wear, participants will wear bilateral control contact lenses for a further 2 months. Standard spectacles made with single vision lenses will be worn. A single vision spectacle lens will serve as the control, and a single vision spectacle lens with a spectacle film adhered on top of the spectacle lens containing an edge pattern will serve as the test. The spectacle film is made from polycarbonate material. Participants will control spectacle lenses bilaterally for 6 months. A cross-over will occur at 6 months and participants will wear spectacle test bilaterally for a further 6 months. . The minimum wear time for spectacles will be 5 days per week and 6 hours per day, with no daily maximum. Participants will choose a frame design from a designated pool of standard frames. Fittings will be confirmed by an optometrist. The distance power of the spectacle lenses will be power matched to the participant's myopic refractive error. At the conclusion of 12 months of wear, participants will wear bilateral control spectacle lenses for a further 2 months. Each participant will attend 9 visits comprising visit 1 (baseline), visit 2 (study product dispensed), visit 3, visit 4, visit 5 (cross-over occurs), visit 6, visit 7, visit 8 (cross-over occurs), and visit 9. Visit 1 will be approximately 45 min duration and visits 2-9 will be approximately 30 min duration. The timing between visits 1 and 2 will be approximately 2 weeks. The timing between visits 2-9 will be approximately 2 months. Visit 1 will comprise standard subjective refraction, measurement of visual acuity obtained with refraction, and measurement of axial length. A standard Snellen visual acuity chart will be used to measure visual acuity and a standard optical biometer will be used to measure axial length. Visual acuity with study product and axial length will be measured at visits 2-9. All assessments will be carried out by an optometrist. Participants will be instructed to wear study product as per the schedule and to return all study product. There is no 'wash-out' period at the cross-over (visit 5). Compliance will be assessed by verbal questioning of participants.
Sponsors
nthalmic Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed