None listed
Conditions
Brief summary
The primary purpose of this study is to compare the differences between two daily disposable contact lenses over a period of 30 days. The study will compare the visual performance, lens comfort and handling between the two lenses. Given the similarity in their design, it is hypoethised that there will be minimal differences between the 2 lenses, in regards to vision, comfort and lens handling.
Interventions
Two silicone hydrogel daily disposable contact lenses will be compared to assess visual performance, lens comfort and handling. The test lens has a water content of 43% with a centre thickness of 0.07mm (-3.00D) and the control lens has a water content of 56% with a centre thickness of 0.03mm (-3.00D). Study participants will be randomly allocated to wear the test or control lens, which they will wear for 30 days. There will be 3 visits. Visit #1, the baseline and initial assessment visit; Visit
Two silicone hydrogel daily disposable contact lenses will be compared to assess visual performance, lens comfort and handling. The test lens has a water content of 43% with a centre thickness of 0.07mm (-3.00D) and the control lens has a water content of 56% with a centre thickness of 0.03mm (-3.00D). Study participants will be randomly allocated to wear the test or control lens, which they will wear for 30 days. There will be 3 visits. Visit #1, the baseline and initial assessment visit; Visit #2, the entry visit and Visit #3, 30 days after Visit #2, the exit visit. All visits are 1 hour in length. Lens are on a daily wear basis for 30 days with comfort and vision assessed at all visits and between visits. Lens wearing compliance will be confirmed by participants returning lens blister packaging at Visit #3. Participants and investigators will be masked from the lens type worn.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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. * Spherical prescription range of -10.00DS to +6.00DS and cylinder less than or equal to 0.75DC) * Correctable to at least 6/7.5 (20/25) or better in each eye with contact lenses. * Must be an experienced contact lens wearer. * Be able to insert and remove contact lenses.
Exclusion criteria
* Any pre-existing ocular irritation, injury or condition (including infection or inflammation) 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. * Currently enrolled in another clinical trial impacting ocular health, vision or systemic conditions/medications (as noted above), which may impact habitual ocular health and vision and the ability to perform the relevant testing required for the current clinical trial. * Pregnancy. * The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfill the clinical trial requirements or it is believed to be in the participant’s best interests. *Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
Outcome results
None listed