None listed
Conditions
Brief summary
This trial will compare the clinical performance of somofilcon A and formofilcon B contact lenses worn for two weeks. The hypothesis is the subjective responses with test lenses are not different to the control contact lenses.
Interventions
This trial will be a prospective, bilateral, randomised, double-masked, cross-over masked clinical trial. Participants will wear two lens typfor two weeks on a single-use, daily wear basis with a minimum two day wash-out between lens types. The lens types are formofilcon B and somofilcon A. Both lens types are classified as silicone-hydrogel material with water contents of 48% and 56% respectively. Lenses will be power-matched for each participant. Minimum wearing time will be 5 days/week and 6
This trial will be a prospective, bilateral, randomised, double-masked, cross-over masked clinical trial. Participants will wear two lens typfor two weeks on a single-use, daily wear basis with a minimum two day wash-out between lens types. The lens types are formofilcon B and somofilcon A. Both lens types are classified as silicone-hydrogel material with water contents of 48% and 56% respectively. Lenses will be power-matched for each participant. 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. There will five visits: Baseline, Stage 1: lens fit, Stage 1: 2-week visit, Stage 2: lens fit, Stage 2: 2-week visit. 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). All contact lenses will be prescribed and all assessments will be carried out by an optometrist. Participants will be instructed to return all used lens packets and any unused contact lenses.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
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, male or female. 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. Be correctable to at least 6/12 (20/40) or better in each eye with contact lenses. Be an experienced 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, 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. 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