None listed
Conditions
Brief summary
The purpose of this trial is to assess the visual performance of a monthly, centre-near multifocal contact lens available in two near additions against two commercially-available equivalents. Participants will each lens for one month on a daily wear basis.
Interventions
This trial will be a prospective, bilateral, randomized, single-masked (participant), cross-over clinical trial. Participants will wear three different multifocal contact lenses (two control and one test). All contact lenses will be worn on a daily-wear basis for one month, with overnight disinfection utilising a commercially available multipurpose solution. All contact lens materials are commercially available in Australia. Test contact lenses are a centre-near design available in two reading a
This trial will be a prospective, bilateral, randomized, single-masked (participant), cross-over clinical trial. Participants will wear three different multifocal contact lenses (two control and one test). All contact lenses will be worn on a daily-wear basis for one month, with overnight disinfection utilising a commercially available multipurpose solution. All contact lens materials are commercially available in Australia. Test contact lenses are a centre-near design available in two reading additions. Two control lenses will be used. One control utilises a centre-near design and is available in three reading additions. The centre-near designs of test and control lenses are different. The other control utilises a combination of centre-distance / centre-near designs and is available in four near additions for each design. The distance power of each contact lens will be matched to correct the participant’s distance ametropia. Each participant will attend 4 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), and visit 4 (third lens assessment). Visit 1 will be approximately 90 minutes duration, visits 2-3 approximately 60 minutes, and visit 4 approximately 30 minutes. Visit 1 will comprise standard subjective refraction and near addition calculation. Distance visual acuity will be measured with subjective refraction using a standard logMAR visual acuity chart, and near visual acuity with be measured with subjective refraction plus near addition using a standard logMAR visual acuity chart. The anterior eye will be assessed with a slit lamp biomicroscope, which is a specialised microscope specifically used to observe the eye. The first randomly allocated lens will be fitted, and lens powers will be optimised for each participant. The final optimised lens will be dispensed. Visits 2-3 will comprise participants attending while wearing allocated lenses. Visual acuities will be measured at both distance and near using standard logMAR visual acuity charts. Subjective performance will be assessed via a numeric rating scale for vision and comfort. A Likert scale will be used to assess lens handling. Both the numeric rating scales and Likert scale used in this study are non-validated metrics. Lens fitting will be assessed on eye using standard optometric techniques (slit lamp biomicroscopy) and nomenclature (lens centration, movement, and tightness). Contact lenses will be removed and the ocular surface will be assessed using standard optometric techniques (slit lamp biomicroscopy) and nomenclature (validated Efron 0-4 grading scales). Used contact lenses will be discarded and unused contact lenses will be collected. The next randomly allocated lens will be fitted, and lens powers will be optimised for each participant. The final optimised lens will be dispensed. Visit 4 will comprise participants attending while wearing their final allocated lenses. Visual acuities, subjective performance, lens handling, lens fitting, and the ocular surface will be assessed using the same techniques as per visits 2-3. 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
Menicon Co. Ltd., Japan
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent. Age 40 and above, male or female. Willing to comply with the clinical trial protocol as directed by the Investigator. Agree not to participate in other clinical research for the duration of this clinical trial. Have ocular health findings considered to be “normal” and which would not prevent the participant from safely wearing contact lenses. Contact lens wear experience in the past 5 years. Best corrected spectacle acuity of at least 6/7.5. Have no more than 1.00 D of astigmatism. Can be fitted with multifocal soft contact lenses within the power range available. Able to obtain a binocular contact lens high contrast visual acuity of at least 6/7.5 with study contact lenses. Willing and able to wear each study contact lens for about one month on a daily wear basis, for at least 5 days per week and 7 hours per day.
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, immunosuppressive 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. Corneal distortion resulting from previous hard or rigid lens wear or keratoconus. Use of or a need for concurrent category S3 and above ocular medication at enrolment. Eye surgery within 12 weeks immediately prior to enrolment for this trial. Previous corneal refractive surgery or cataract surgery. Contraindications to contact lens wear. Known allergy or intolerance to ingredients in any of the clinical trial products. Currently enrolled in another contact lens or lens care solution clinical trial within the last two weeks. Currently wearing one of the contact lenses used in the study. Pregnancy* or lactating at time of enrolment. 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. *Formal testing of pregnancy is not required. A participant’s verbal report is enough.
Outcome results
None listed