None listed
Conditions
Brief summary
This is a prospective, cross-over clinical trial to determine the effect of filters, myopia control spectacles and soft contact lenses on the contrast sensitivity function. Up to 30 prototype designs may be assessed during the study. Up to 20 participants (minimum of 10) will be included in the evaluation of each prototype design. The contrast sensitivity function (plotting of contrast thresholds at various spatial frequencies) obtained with filters, myopia control spectacles and soft contact lenses will be compared to the contrast sensitivity function obtained with single vision spectacles and soft contact lenses. Healthy adults aged at least 18 years old will be recruited. Habitual spectacle wearers, experienced and inexperienced contact lens wearers will be recruited.
Interventions
This is a prospective, cross-over clinical trial to determine the effect of filters, myopia control spectacles and soft contact lenses on the contrast sensitivity function. Up to 30 prototype designs may be assessed during the study. Up to 20 participants (minimum of 10) will be included in the evaluation of each prototype design. The contrast sensitivity function (plotting of contrast thresholds at various spatial frequencies) obtained with filters, myopia control spectacles and soft contact le
This is a prospective, cross-over clinical trial to determine the effect of filters, myopia control spectacles and soft contact lenses on the contrast sensitivity function. Up to 30 prototype designs may be assessed during the study. Up to 20 participants (minimum of 10) will be included in the evaluation of each prototype design. The contrast sensitivity function (plotting of contrast thresholds at various spatial frequencies) obtained with filters, myopia control spectacles and soft contact lenses will be compared to the contrast sensitivity function obtained with single vision spectacles and soft contact lenses. Healthy adults aged at least 18 years old will be recruited. Habitual spectacle wearers, experienced and inexperienced contact lens wearers will be recruited
Sponsors
Brien Holden Vision Institute Limited
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Be at least 18 years, male or female. Astigmatism less than or equal to -2.00 D in both eyes. Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. 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 right eye with or without correction Be habitual spectacle wearers, experienced or inexperienced contact lens wearers.
Exclusion criteria
.• Have strabismus and/or amblyopia. • Astigmatism more than- 2.00 D in either eye. • Any ocular and central nervous system anomalies. • 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 prior to enrolment for this trial. • Previous corneal refractive surgery. • 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*.
Outcome results
None listed