None listed
Conditions
Brief summary
This study will compare solution induced corneal staining rates between three PHMB-based solutions at 2 hours hours and 8 hours, when used with balafilcon A and senofilcon A contact lenses. The hypothesis is there will no difference in solution induced corneal staining rates between the three solutions
Interventions
This is a prospective, doubled-masked, cross-over, randomised clinical trial where 55 participants will contralaterally wear contact lenses made from balafilcon A and senofilcon A material. The trial will be run in two sequential Parts of three randomised stages each, with each stage corresponding to one solution. All three stages in Part 1 of the trial will utilise plano contact lenses (i.e. contact lenses with no power) while all three stages in Part 2 will utilise power-matched lenses (i.e. c
This is a prospective, doubled-masked, cross-over, randomised clinical trial where 55 participants will contralaterally wear contact lenses made from balafilcon A and senofilcon A material. The trial will be run in two sequential Parts of three randomised stages each, with each stage corresponding to one solution. All three stages in Part 1 of the trial will utilise plano contact lenses (i.e. contact lenses with no power) while all three stages in Part 2 will utilise power-matched lenses (i.e. contact lenses that have a participant’s power in them). Each stage will have two visits, both of which occur on the same day- dispensing of lenses and assessment after a period of lens wear. The period of wear is for stages in Part 1 will be 2 hours, and in Part 2 the period of wear will be 8 hours. New lenses will be used for each stage. Prior to use for any stage, lenses will be removed from packaging and stored in a standard, flat contact lens case (two wells, one well for each contact lens and capacity of each well approximately 5ml) and soaked overnight in either a PHMB-based new solution or PHMB-based commercially available solutions COMPLETE [Registered trade mark] Easy Rub [Registered trade mark] and renu [Registered trade mark] fresh [Trademark]. For any stage of any Part, solution will only be used to soak lenses overnight and no solution will be given to participants. There are six stages in total (two parts, three stages in each part) with participants to complete all stages. There is a minimum 24 hour wash-out period between stages.
Sponsors
Abbott Medical Optics, Inc
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 an experienced contact lens wearer; -Be able to insert and remove contact lenses; -Be willing to not wear contact lens wear for at least 24 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, 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 study; -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 study; N.B.: Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial and at least 24 hours before study 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 study 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*; -The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the study requirements, or if 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