None listed
Conditions
Brief summary
This is a clinical trial to assess the visual performance of a new (prototype) soft contact lens for astigmatism compared to commercially available soft contact lenses. Astigmatism is a common eye condition where images at all distances can be blurred to variation in the shape of the surface of the eye. To assess the visual performance we wish to monitor your eyes' response to the products and what you think of them.
Interventions
Participants will wear a prototype(test) soft contact lens for astigmatism bilaterally. An optometrist will fit participants with the assigned study lens and check its performance prior to dispensing lenses to participants. Participants will wear each lens for a minimum of 3 days in a week (up to 7 days a week) consistent with the participant's usual amount of contact lens wear. Up to two take home questionnaires will be completed on one time point between days 2-6 (depending on the number of da
Participants will wear a prototype(test) soft contact lens for astigmatism bilaterally. An optometrist will fit participants with the assigned study lens and check its performance prior to dispensing lenses to participants. Participants will wear each lens for a minimum of 3 days in a week (up to 7 days a week) consistent with the participant's usual amount of contact lens wear. Up to two take home questionnaires will be completed on one time point between days 2-6 (depending on the number of days contact lenses are worn) . Between each lens type, there will be a washout period of 2 nights. To monitor adherence, participants will return unused lenses and foils of used lenses.
Sponsors
Brien Holden Vision Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 40 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. * Have astigmatism between -0.75 D and -2.00D. * 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 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. However, 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. * Currently enrolled in another clinical trial.
Outcome results
None listed