None listed
Conditions
Brief summary
The purpose of this study is to assess the visual performance of prototype contact lenses with a tinted edge pattern compared to commercially available single vision contact lens and myopia management contact lens.
Interventions
This will be a prospective, randomised, cross-over, bilateral clinical trial. All participants will be randomised to wear three different soft contact lenses. The contact lenses are made from either ocufilcon D or omafilcon A and are replaced daily. A single vision contact lens and a myopia management contact lens will serve as the controls and a single vision contact lens with a tinted edge pattern will served as the test.
Contact lens wear will be for a minimum of 5 days.
Each participant will
This will be a prospective, randomised, cross-over, bilateral clinical trial. All participants will be randomised to wear three different soft contact lenses. The contact lenses are made from either ocufilcon D or omafilcon A and are replaced daily. A single vision contact lens and a myopia management contact lens will serve as the controls and a single vision contact lens with a tinted edge pattern will served as the test. Contact lens wear will be for a minimum of 5 days. Each participant will attend 4 visits comprising: Visit 1 (Baseline/Dispensing 1): Standard subjective refraction, visual acuity, ocular health, and axial length will be measured. The first randomised contact lens will be fitted and dispensed. Visual acuity and lens fitting will be measured, and lens surface will be assessed. The approximate duration is 60 minutes. Visit 2 (Assessment 1/Dispensing 2): Assessment of the first dispensed contact lenses will occur and involve subjective assessment, visual acuity, binocular vision, lens fitting, lens surface, ocular health, and axial length measurements. The second randomised contact lens will be fitted and dispensed. Visual acuity and lens fitting will be measured, and lens surface will be assessed. The approximate duration is 60 minutes. Visit 3 (Assessment 2/Dispensing 3): Assessment of the second dispensed contact lenses will occur and involve subjective assessment, visual acuity, binocular vision, lens fitting, lens surface, ocular health, and axial length measurements. The third randomised contact lens will be fitted and dispensed. Visual acuity and lens fitting will be measured, and lens surface will be assessed. The approximate duration is 60 minutes. Visit 4 (Assessment 3): Assessment of the third dispensed contact lenses will occur and involve subjective assessment, visual acuity, binocular vision, lens fitting, lens surface, ocular health, and axial length measurements. The approximate duration is 30 minutes. Non-validated questionnaires will be used for subjective assessment of visual performance. Visual acuity will be measured using a standard Snellen letter chart. A standard optical biometer will be used to measure axial length. A slit lamp biomicroscope will be used to assess ocular health, contact lens fitting, and the contact lens surface. Binocular vision measurements comprise heterophoria, monocular accommodative facility, and accommodative response, and will be measured utilising standardised optometric techniques using standard phoria cards, standard flippers, and a standard open-field autorefractor, respectively. All visits will be performed by an optometrist. Compliance will be assessed via questionnaires and verbal questioning.
Sponsors
nthalmic Pty Ltd
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 40 Years
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 aged at least 18 years and less than 40 years, male or female. Willing to comply with the clinical trial 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 experience with wearing contact lenses. Have myopia greater than 0.75 D and no more than 6.00 D. Have best-corrected visual acuity at least 6/7.5 (0.1 logMAR)
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. 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 while wearing study lenses. 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 at time of enrolment – verbal report sufficient.
Outcome results
None listed