None listed
Conditions
Brief summary
To assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens.
Interventions
The contact lenses being studied are prototype soft contact lenses made from Etafilcon A material. The lenses differ only in their power profile - all are made from the same material. The contact lens powers will range from +3.00 to -6.00D in 0.25 steps for non presbyopes and for presbyopes from +3.00 to -6.00D in 0.25 steps for low, mid and high adds (range from +0.75 to +2.50D).
Participants will test 1 pair of prototype soft contact lenses. Lenses will be inserted bilaterally on the particip
The contact lenses being studied are prototype soft contact lenses made from Etafilcon A material. The lenses differ only in their power profile - all are made from the same material. The contact lens powers will range from +3.00 to -6.00D in 0.25 steps for non presbyopes and for presbyopes from +3.00 to -6.00D in 0.25 steps for low, mid and high adds (range from +0.75 to +2.50D). Participants will test 1 pair of prototype soft contact lenses. Lenses will be inserted bilaterally on the participant by the investigating optometrist, and worn for a maximum of 1 hour. A minimum of an overnight wash out period will be required between the lens visits.
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
7 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 7 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 with both eyes with contact lenses. Be suitable and willing to wear contact lenses.
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, Sjögrens 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