None listed
Conditions
Brief summary
The purpose of this study is to compare the clinical performance (defined by visual acuity measurements, subjective response, lens surface characteristics and ocular physiological characteristics) of a commercially-available (Europe and Japan) contact lens (SEED Pure) against commercially-available (Australia) contact lenses (Proclear and Vita). To achieve this, participants will wear one of these for 3 months on a daily-wear basis with monthly replacement. All participants will use Alcon Puremoist multipurpose disinfection solution. Our hypotheses are there will be no difference between lens types for visual acuity, subjective response, lens surface characteristics and ocular physiological characteristics.
Interventions
This trial will be a prospective, bilateral, randomised, open-label clinical trial. Participants will wear one of three lens types for three months with monthly replacement daily wear basis in conjunction with OPTI-FREE Puremoist multipurpose disinfecting solution. The three lens types comprise:
Commercially-available (Europe and Japan) single vision lenses manufactured by SEED and made from SEED ionic bond (SIB) material: Base curve: 8.6 mm, Diameter: 14.2 mm, Power Range: -0.75 to -6.00 D.
Co
This trial will be a prospective, bilateral, randomised, open-label clinical trial. Participants will wear one of three lens types for three months with monthly replacement daily wear basis in conjunction with OPTI-FREE Puremoist multipurpose disinfecting solution. The three lens types comprise: Commercially-available (Europe and Japan) single vision lenses manufactured by SEED and made from SEED ionic bond (SIB) material: Base curve: 8.6 mm, Diameter: 14.2 mm, Power Range: -0.75 to -6.00 D. Commercially-available (Australia) lenses single vision lenses manufactured by Johnson & Johnson and made from senofilcon C material: Base curve: 8.4 mm, Diameter: 14 mm, Power Range: -0.75 to -6.00 D. Commercially-available (Australia) lenses single vision lenses manufactured by CooperVision and made from omafilcon A material: Base curve: 8.6 mm, Diameter: 14 mm, Power Range: -0.75 to -6.00 D. At each visit, investigators will ensure that participants have one pair of lenses to wear and one spare pair of lenses. Minimum wearing time will be 5 days per week and 6 hours per day when lenses are worn with no maximum wearing time provided lenses are not slept in overnight. There will 5 visits comprising Baseline and four follow-up visits at 2-weeks, 1-month, 2-months, 3-months after Baseline. Each visit will be approximately 45 minutes in duration. Baseline visits will comprise auto-refraction, subjective refraction with visual acuity measurement, ocular assessment with a slit-lamp biomicroscope (a specialized microscope for viewing the eye, lens fitting, lens assessment with slit-lamp biomicroscope and questionnaire (see below). All assessment visits will comprise questionnaires (see below), visual acuity measurement and lens and ocular assessment with slit-lamp biomicroscope. Questionnaires will be completed at all visits, and will utilise numeric rating scales (1-10 in 1-point steps) and 6-point Likert scales. All contact lenses will be prescribed and all assessments will be carried out by an optometrist. Participants will be instructed to return all unused contact lenses not commercially-available in Australia.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
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. Is correctable to at least 6/7.5 (20/25) or better in each eye with best-corrected subjective refraction and 6/12 (20/40) or better in each eye with contact lenses. Can be an experienced or first time (neophyte) contact lens wearer. Be able to insert and remove 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, 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*. 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. *Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
Outcome results
None listed