None listed
Conditions
Brief summary
The aim of this study is to assess the visual performance and wearability of prototype ophthalmic lenses compared to commercially available ophthalmic lenses.
Interventions
This is a randomized single-masked (participant) crossover study design. Participants will attend for two study visits for each of the three lens designs (two prototypes and one control lens design). Each cross over period is separated by a one day wash out (1 night).
• Following randomization, the participant will attend for Phase 2 visits. At Phase 2 – Visit 1(1.5hr) the randomized study lenses will be fitted by the optometrist using the study frame and the assessments will be performed. The o
This is a randomized single-masked (participant) crossover study design. Participants will attend for two study visits for each of the three lens designs (two prototypes and one control lens design). Each cross over period is separated by a one day wash out (1 night). • Following randomization, the participant will attend for Phase 2 visits. At Phase 2 – Visit 1(1.5hr) the randomized study lenses will be fitted by the optometrist using the study frame and the assessments will be performed. The order for the study measures will be the same as Phase 1 study visit. • The participant will return for the Phase 2 – Visit 2(1.5hr) after a minimum of two days of bilateral spectacle wear and the assessments will be performed. The order for the study measures will be the same as Phase 1 study visit (except only one measure for Choroidal thickness and axial length measures are required). Two days are defined where the study visits are separated by two nights. • Study Visit 2 exit; on completion of study visit 2 the Phase 0 lenses will be refitted to the study frame. • The lens power of each product will be based on the spherical equivalent of the best-corrected subjective refraction found at baseline. After completing all six of the Phase 2 study visits the participant will exit the clinical trial. - The two prototype ophthalmic lens design consist of a central zone with refractive power matched to the participant’s prescription, with a peripheral zone of different refractive power. The two prototypes differ in peripheral refractive power. -For the 2 days of bilateral spectacle wear a) participant need to wear the spectacles for all waking hours b) strategies for adherence included participant questionnaires that probe compliance, history taking investigating level of compliance/non-compliance at every visit. -Phase 0 ophthalmic lenses consist of a standard single vision lens , Miyosmart myopia management lens , Stellest myopia management lens , and two prototype myopia management lens designs .
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
Age in complete years ranging from 18 to 35 years, male or female. • Myopic spherical equivalent non-cycloplegic subjective refractive error between -0.50D to -6.50D and cylinder up to and including -0.75DC • Vision of 6/7.5 (20/25) or better in each eye with or without correction • Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. • Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator. • Have ocular health findings considered to be “normal”.
Exclusion criteria
Have strabismus and/or amblyopia. • Any pre-existing ocular irritation, injury or condition (including infection or disease) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses. • Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant’s ocular health / physiology or contact lens performance either in an adverse or beneficial manner at enrolment and/or during the clinical trial. • Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. • Eye surgery within 12 weeks immediately prior to enrolment for this trial. • Previous corneal refractive surgery. • Known allergy or intolerance to ingredients in any of the clinical trial products. • Currently enrolled in another clinical trial. • Pregnancy*. The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests. *Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
Outcome results
None listed