None listed
Conditions
Brief summary
To evaluate the clinical performance and subjective responses of commercially available Focus (registered trademark) 1-2 Week, Focus (registered trademark) Monthly and FreshLook (registered trademark) Handling Tint lenses in a sample of East Asian population when the lenses are worn on a daily wear, daily disposal schedule.
Interventions
Prospective, open label, randomised, crossover trial to assess the performance of contact lenses made from vifilcon A and phemfilcon A when worn for 1 month each over a 3 month period (with 1 day washout between switching lenses) on a daily wear, daily disposable schedule.
Sponsors
CIBA VISION
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
-Be 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; -Be of East Asian ethnicity (either Japanese, Chinese, Taiwanese or Korean); -Be 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; -Have vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses; -Be experienced or may be inexperienced at wearing contact lenses. -Have a current spectacle correction.
Exclusion criteria
-Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) 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 erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants; -An active corneal infection or any active ocular disease that would affect wearing of contact lenses; -Use of or a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial; -Use of or a need for any systemic medication or topical medications or participation in any clinical trial which may alter normal ocular findings/are known to affect a participant’s ocular health/physiology or contact lens performance either in an adverse manner or risk providing a false positive. N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial; -Eye surgery within 12 weeks immediately prior to enrolment for this trial; -Previous corneal refractive surgery; -Contraindications to contact lens wear; -Contact lens wear within 1 calendar day of initial lens fitting (washout period to be performed post enrolment if necessary) -Allergy or intolerance to topical anaesthetics
Outcome results
None listed