None listed
Conditions
Brief summary
This trial will examine the effect of a novel multipurpose contact lens solution on subjective response and the ocular surface. The hypotheses are these outcomes will be similar for control solutions.
Interventions
This is a prospective, randomised (solution allocation), bilateral, cross-over clinical trial where a minimum of 30 experienced contact lens wearers will use a commercial multipurpose solution (MPS) (OPTI-FREE (Registered Trademark) Puremoist (Registered Trademark)) (OFPM) and a novel MPS (BHVI7) in conjunction with Clariti (Trademark) and or ACUVUE (Registered Trademark) OASYS (Trademark) contact lenses on a daily wear basis for approximately two or four months. There will be 2 or 4 stages in t
This is a prospective, randomised (solution allocation), bilateral, cross-over clinical trial where a minimum of 30 experienced contact lens wearers will use a commercial multipurpose solution (MPS) (OPTI-FREE (Registered Trademark) Puremoist (Registered Trademark)) (OFPM) and a novel MPS (BHVI7) in conjunction with Clariti (Trademark) and or ACUVUE (Registered Trademark) OASYS (Trademark) contact lenses on a daily wear basis for approximately two or four months. There will be 2 or 4 stages in this study, with each stage corresponding to using one of the MPS for one month. There will be 8 or 16 scheduled visits, with 4 visits per stage: baseline/dispensing visit, 2 hour post insertion, 2 weeks and 1-month visits. 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. All solutions will be used after lens removal and as per manufacturer’s recommendation: 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. Clariti contact lenses will be replaced monthly and ACUVUE OASYS 2-weekly. There will be a 48 hour wash-out where no contact lenses are worn before the commencement of each stage.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
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. Be experienced at wearing contact lenses. 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. Correctable to at least 6/12 or better in each eye with contact lenses. Be willing to not wear contact lenses for at least 2 days before each stage of the clinical trial.
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 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 2 days between in-house studies. Pregnancy* (Formal testing of pregnancy is not required. A participant’s verbal report is sufficient)
Outcome results
None listed