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 study consist of two phases;
Phase 0: The participant will attend a single Phase 0 visit where the pre-ordered single vision lenses will be fitted into the study spectacle frame and assessments will be performed.The study questionnaires will be completed 1 hour following dispensing of the Phase 0 spectacles.
The purpose of Phase 0 is to ensure all study participants have:
• A preselected spectacle frame to allow trial lenses to be fitted immediately into that frame at the start of each tria
This study consist of two phases; Phase 0: The participant will attend a single Phase 0 visit where the pre-ordered single vision lenses will be fitted into the study spectacle frame and assessments will be performed.The study questionnaires will be completed 1 hour following dispensing of the Phase 0 spectacles. The purpose of Phase 0 is to ensure all study participants have: • A preselected spectacle frame to allow trial lenses to be fitted immediately into that frame at the start of each trial cycle. • Adapted to the standard spectacles lenses which have the same base curve, lens material and anti-reflection coating as the prototype study lenses. The participant will be dispensed the single vision lenses and required to wear for at least a single day prior to attending initial Phase 1 or 2 visits. Phase 1: At Phase 1 (Non dispensing phase); minimum of 3 to up to 10 visits- 1 visit per lens type. -Each study visit (1.5 hours); non-dispensing lens wearing period of a minimum of 1 hour Study Visit 1 the study lenses will be fitted into the study frame and the assessments will be performed by the study optometrist. The study lens order will be non-randomised.. • Participants may trial multiple study lenses in Phase 1 with a minimum of 60-minute washout period between lens design assessments. -Each participant may evaluate up to two study lens designs on a single day. -The number of lenses participants receive will be primarily determined by participant availability, so long as protocol criteria is met (i.e. each participant must test at least one control and one test lens, and, each test lens must be tested by 10 different participants). -The distinguishing features of the four test lenses relate to the magnitude, rate, and distribution profile of the peripheral power progression. All four lenses differ in this regard.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
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