None listed
Conditions
Brief summary
The purpose of this trial is to assess the visual performance of astigmatic contact lenses compared to dual-focus contact lenses.
Interventions
This trial will be a prospective, bilateral, randomized, single-masked (participant), cross-over clinical trial. Participants will wear up to 6 different test contact lens designs and one control contact lens. All contact lenses will be worn on a daily-wear basis for one week. All test lenses are toric and the control lens is a commercially available dual-focus lens.
The distance power of each contact lens will be matched to correct the participant’s myopia.
Each participant will attend for a m
This trial will be a prospective, bilateral, randomized, single-masked (participant), cross-over clinical trial. Participants will wear up to 6 different test contact lens designs and one control contact lens. All contact lenses will be worn on a daily-wear basis for one week. All test lenses are toric and the control lens is a commercially available dual-focus lens. The distance power of each contact lens will be matched to correct the participant’s myopia. Each participant will attend for a maximum of 8 visits, comprising visit 1 (baseline and first lens fitting), visit 2 (first lens assessment and second lens fitting), visit 3 (second lens assessment and third lens fitting), visit 4 (third lens assessment and fourth lens fitting), visit 5 (fourth lens assessment and fifth lens fitting), visit 6 (fifth lens assessment and sixth lens fitting), visit 7 (sixth lens assessment, seventh lens fitting) and visit 8 (seventh lens assessment). Visit 1 will be approximately 90 minutes duration, visits 2-7 approximately 60 minutes, and visit 8 approximately 30 minutes. Visit 1 will comprise standard subjective refraction and measurement of visual acuity obtained with refraction. A standard logMAR visual acuity chart will be used. Power-matched spherical contact lenses will be fitted with a view to obtaining the distance lens power that will be initially used to fit all test and control lenses. The first allocated lens will be dispensed. Visits 2-7 will comprise participants attending while wearing allocated lenses. Visual acuity will be measured, and visual performance will be assessed via a numeric rating scale. A standard logMAR visual acuity chart will be used to measure visual acuity, and the numeric rating scale used in this study is a non-validated metric. Used contact lenses will be discarded and unused contact lenses will be collected. The next randomly allocated lens will be dispensed. Visit 8 will comprise participants attending while wearing randomly allocated lenses. Visual acuity will be measured, and visual performance will be assessed. Both procedures will be performed using the same techniques used in visits 2-7. Used contact lenses will be discarded and unused contact lenses will be collected. All contact lenses will be prescribed, and all assessments will be carried out by an optometrist. Participants will be instructed to wear allocated study lenses to each visit and to return all unused lenses. There is no ‘wash-out’ period between treatments. Compliance will be assessed by verbal questioning of the participant.
Sponsors
nthalmic Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
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 at least 18 years of age but less than 40 years of age, 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.
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. The Investigator may, at their 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