None listed
Conditions
Brief summary
This study aims to compare a recently released contact lens product to the current market leader. By comparing these lenses, it will allow us to ascertain whether these newly released lenses have achieved their claim. In addition, if the recently released contact lens product is found to be superior to the market leader, further investigations into why it is superior can benefit in the understanding of why contact lens related discomfort and dryness occur and allow for development of further new products to solve this problem.
Interventions
At the Baseline visit, if participants has attended with a 2 days of no lens wear period, they are fitted with both the DAILIES TOTAL 1[RegisteredTradeMark] and ACUVUE[RegisteredTradeMark] OASYS[TradeMark] lenses as per the randomisation for eyes (different lens on each eye). After 8 hours of lens wear, participants are to return for ocular health exams and lenses are removed and discarded. After 2 days of washout period, they are asked to return for Stage 2 dispensing visit where they will be d
At the Baseline visit, if participants has attended with a 2 days of no lens wear period, they are fitted with both the DAILIES TOTAL 1[RegisteredTradeMark] and ACUVUE[RegisteredTradeMark] OASYS[TradeMark] lenses as per the randomisation for eyes (different lens on each eye). After 8 hours of lens wear, participants are to return for ocular health exams and lenses are removed and discarded. After 2 days of washout period, they are asked to return for Stage 2 dispensing visit where they will be dispensed the DAILIES TOTAL 1[RegisteredTradeMark] and ACUVUE[RegisteredTradeMark] OASYS[TradeMark] lenses. At this visit, the randomisation of the lenses to the eyes will be swapped (ie. if DAILES TOTAL1 worn on right eye in Stage 1, it would be ACUVUE OASYS worn on right eye in Stage 2). Ocular health and subject comfort rating questionnaires are completed at Baseline, 8 hours after lens wear, Stage 2 Dispensing and 8 hours after lens wear (Stage 2)
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 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 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. Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses. Be experienced in wearing contact lenses. Be able to insert and remove contact lenses. Be willing to not wear contact lenses for at least 48 hours before each stage of the clinical trial (after informed consent).
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 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. Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies. Pregnancy
Outcome results
None listed