None listed
Conditions
Brief summary
This trial will compare the clinical performance of formofilcon B silicone hydrogel and etafilcon A hydrogel contact lenses against commercial silicone hydrogel and hydrogel contact lenses when worn for 30 days. The hypothesis is the subjective responses with test lenses are not different to the control contact lenses.
Interventions
This trial will be a prospective, parallel, unmasked clinical trial. Participants will wear at least one lens for 30 days using a specified lens care solution if required. A minimum of 40 participants will be included in the evaluation of each lens type and up to 400 participants may be enrolled in the trial. All lenses will be worn bilaterally, on a daily wear basis for 30 days (1 month). Minimum wearing time will be 5 days/week and 6 hours/day. There is no maximum wearing time provided lenses
This trial will be a prospective, parallel, unmasked clinical trial. Participants will wear at least one lens for 30 days using a specified lens care solution if required. A minimum of 40 participants will be included in the evaluation of each lens type and up to 400 participants may be enrolled in the trial. All lenses will be worn bilaterally, on a daily wear basis for 30 days (1 month). Minimum wearing time will be 5 days/week and 6 hours/day. There is no maximum wearing time provided lenses are not slept in overnight. Lenses which may be assessed include re-usable, monthly replacement silicone hydrogel lenses (filcon 1, somofilcon A, comfilcon A), single-use, daily disposable silicone hydrogel lenses (filcon 1, formofilcon B, stenfilcon A, somofilcon A). and single-use, daily disposable hydrogel lenses (etafilcon A, omofilcon A). Solutions which may be used include Biotrue (Trademark), renu (Registered Trademark) fresh (Trademark), OPTI-FREE (Registered Trademark) Puremoist (Registered Trademark), AOSEPT (Registered Trademark) Plus, Revitalens OcuTec (Registered Trademark) and Complete (Registered Trademark) Easy Rub. Each assessment will have 3 visits: Baseline/dispensing, 2 weeks and 1 month. These visits will involve assessment of visual acuity, assessment of ocular comfort using questionnaires employing a 1-10 numeric rating scale and ocular response by examination with a slit-lamp biomicroscope (a specialised microscope for viewing the eye). Lenses will be worn a minimum of 5 days per week, 6 hours per day. Solutions will be used on re-usable lenses after lens removal using a rub/rinse cleaning regime- rub lenses with solution (5 seconds), rinse lenses with solution (5seconds) and store in solution for at least 6 hours. Solution is not to be reused. Lenses will be replaced as per manufacturer’s recommendation (either after 1 month or after single use as specified above). Participants can wear up to 4 different contact lens type. A 2 week wash-out where habitual correction is worn is required when testing more than one lens type.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not 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. May be an experienced or inexperienced lens wearer. Be able to insert and remove contact lenses. Be willing to undergo a 2 week wash-out with habitual correction between lens assessments.
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, Sjorens 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, such ocular medications can be prescribed as per standard optometric care 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. Pregnancy (Formal testing of pregnancy is not required. A participant’s verbal report is sufficient). The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
Outcome results
None listed