Presbyopia, Refractive Error
Conditions
Keywords
Presbyopia, Refractive error correction, Contact lenses
Brief summary
The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens
Detailed description
Prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. A minimum of an overnight washout period is required between the fitting /assessment visits.
Interventions
DEVICEEtafilcon A, Senofilcon A
1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).
Sponsors
Brien Holden Vision
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
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. * Eye surgery within 12 weeks immediately prior to enrolment for this 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual performance | After about 20 minutes of lens wear | Visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective responses | After about 40 minutes of lens wear | Subjective ratings of vision |
Countries
Australia
Outcome results
None listed