None listed
Conditions
Brief summary
The purpose of this study is to compare the visual performance (defined by visual acuity measurements and subjective ratings) in presbyopes between two different contact lens designs. To achieve this, participants will each wear both lens types for a minimum of 1 month. Outcome measures will comprise visual acuity and subjective ratings. Our hypotheses are there will be no differences between lens type for either visual acuity or subjective ratings.
Interventions
This trial will be a prospective, bilateral, randomized, double-masked, cross-over clinical trial.
Participants will wear two contact lens designs for one month each on a single-use, daily wear basis with a minimum two day wash-out between lens types. Both lens types are designed to correct presbyopia. The materials and parameters for each lens type are: nelfilcon A, base curve = 8.7 mm, diameter = 14.0 mm, power range = +3.00 to -6.00 (low / med / high). SEED 1day PureMoisture: base curve = 8.8
This trial will be a prospective, bilateral, randomized, double-masked, cross-over clinical trial. Participants will wear two contact lens designs for one month each on a single-use, daily wear basis with a minimum two day wash-out between lens types. Both lens types are designed to correct presbyopia. The materials and parameters for each lens type are: nelfilcon A, base curve = 8.7 mm, diameter = 14.0 mm, power range = +3.00 to -6.00 (low / med / high). SEED 1day PureMoisture: base curve = 8.8 mm, diameter = 14.2 mm, power range = +3.00 to -6.00 (low / mid / high). The minimum wearing time will be 5 days per week and 6 hours per day when lenses are worn, with no maximum wearing time provided lenses are not slept in overnight. There will 7 visits comprising Baseline and three visits for each of the two lens designs (Fitting and two Assessment visits). Fitting visits will be performed by unmasked investigators and comprise contact lens fitting, assessment of contact lens visual acuity and assessment of contact lenses on eye with a slit-lamp biomicroscope (a specialized microscope for viewing the eye). Each visit will be approximately 45 minutes in duration. Baseline visits will comprise auto-refraction, subjective refraction with visual acuity measurement and ocular assessment with a slit-lamp biomicroscope (a specialized microscope for viewing the eye). Assessment visits will be performed by masked investigators and comprise assessment of contact lens visual acuity and subjective ratings of vision questionnaire utilizing a 1-10 numeric rating scale. A minimum 2-day wash-out will be observed between lens designs where study lenses are not worn. Participants will wear their habitual vision correction in between wearing study lenses All contact lenses will be prescribed and all assessments will be carried out by an optometrist. Participants will be instructed to bring all unused contact lenses to each of the two Assessment visits. Compliance will be assessed by comparing the number of lenses dispensed to the number of unused lenses, as well as verbal questioning of the participant.
Sponsors
Brien Holden Vision Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
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. Be presbyopic and at least 40 years old, male or female 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 6/12 (20/40) or better in each eye with contact lenses. Be suitable and willing to wear 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, 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. Ocular medication can be prescribed during the course of the trial as per standard optometric practice. 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. 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