None listed
Conditions
Brief summary
To assess visual performance of prototype soft contact lens designs compared to commercially available contact lenses.
Interventions
Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear up to 6 pairs of lenses [up to 4 prototype (test) and up to 2 commercial (control)] lenses bilaterally. All 4 prototype lenses will be multifocal designs and each test lenses will have different amount of add power (+1.25, +1.50, +1.75, +2.00). Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group wi
Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear up to 6 pairs of lenses [up to 4 prototype (test) and up to 2 commercial (control)] lenses bilaterally. All 4 prototype lenses will be multifocal designs and each test lenses will have different amount of add power (+1.25, +1.50, +1.75, +2.00). Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Test lens designs will be assessed against the control/s in each parallel arm in a randomized cross over fashion, with a minimum 2 day washout period between the lens types. Lenses will be worn on a daily wear basis and each lens assessment will require 2 scheduled clinic attendances – a fitting visit on Day 1 and an evaluation visit between Day 5 to Day 7 with 2 take-home questionnaires to be completed between the fitting visit and evaluation visit.
Sponsors
Brien Holden Vision Pty Ltd
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Be at least 18 years old, male or female. Willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator. Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses. Correctable to at least 6/12 (20/40) or better in each eye with contact lenses. Be willing to not wear contact lenses for a minimum of 2 days before each stage of the clinical trial (after informed consent). Have at least +1.00D of Add prescription for presbyopes Have at least -0.50D of myopic prescription for myopes
Exclusion criteria
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. 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. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants. Use of or a need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial. 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. NB: Systemic antihistamines are allowed on an “as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used. Eye surgery within 12 weeks immediately prior to enrolment for this trial. Previous corneal refractive surgery. Contraindications to contact lens wear. Known allergy or intolerance to ingredients in any of the clinical trial products.
Outcome results
None listed