None listed
Conditions
Brief summary
This study aims to find out the visual performance of different prototype contact lenses compared to commercially available contact lenses. The prototype lenses use different optical designs to standard contact lenses by increasing depth-of-focus, and may offer an improved wearing experience.
Interventions
Multiple prototype contact lens designs made from etafilcon A material will be assessed during the study, where each design will be worn daily for up to a week on a daily disposable modality. The prototype lenses are made from etafilcon A, with powers ranging from +3.00 to -6.00, base curve from 8.2mm to 8.7mm, and diameter from 13.8mm to 14.3mm.
Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit on at least Day 7). T
Multiple prototype contact lens designs made from etafilcon A material will be assessed during the study, where each design will be worn daily for up to a week on a daily disposable modality. The prototype lenses are made from etafilcon A, with powers ranging from +3.00 to -6.00, base curve from 8.2mm to 8.7mm, and diameter from 13.8mm to 14.3mm. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit on at least Day 7). There will be a minimum 2-night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit. Prototype lenses all have a multifocal design and each design will be available in +3 to -6 dioptre powers. The difference between the prototype designs are in their manipulation of higher order spherical aberrations via their optics (i.e. differing power distribution throughout the lens), in order to achieve an increased depth of focus. Different manipulations can achieve either different or similar depths of focus. The power profiles of the prototype lenses feature multiple undulations with a smooth rise and fall of optical power as a function of optic cord diameter, and each of the prototype designs have variations of the undulations to provide different amounts of depth-of-focus. Participants will test up to 5 prototype contact lens designs and at least 1 (maximum of 2) control lens (commercially available lens). However, as participants are able to withdraw at any time, the final number of lenses tested by each participant is essentially determined by them. Participants are asked to bring in any leftover lenses to the Assessment Visit as well as the foils of the lens blisters they open and use, to assist us in monitoring adherence.
Sponsors
Brien Holden Vision Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
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 between 18-70 years old, male or female. Have either presbyopia and/or myopia. Have contact lens prescription between -6 to +3D. 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. Is correctable to at least 6/12 (20/40) or better in each eye 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, 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. Ocular medication can be prescribed during the course of the trial as per standard optometric practice. 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