None listed
Conditions
Brief summary
The purpose of this study is to compare the visual performance (defined by visual acuity measurements and subjective ratings) between two optically similar designs that only differ by lens material. To achieve this, participants will each wear both lens types for a minimum of 5 days. 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, randomised, double-masked, cross-over clinical trial.
Participants will wear two lens designs for 5 consecutive days on a single-use, daily wear basis with a minimum two
day wash-out between lens types. The two lens designs will be optically similar and only differ in the contact lens material from which they are made. The parameters and power ranges for both lens will also be the same (base curve = 8.4 mm, diameter = 14 mm, power range = -0.75 to -6.
This trial will be a prospective, bilateral, randomised, double-masked, cross-over clinical trial. Participants will wear two lens designs for 5 consecutive days on a single-use, daily wear basis with a minimum two day wash-out between lens types. The two lens designs will be optically similar and only differ in the contact lens material from which they are made. The parameters and power ranges for both lens will also be the same (base curve = 8.4 mm, diameter = 14 mm, power range = -0.75 to -6.00 D). The two lens materials are etafilcon A and SEED 1dayPure. Minimum wearing time will be 5 days and 6 hours/day with no maximum wearing time provided lenses are not slept in overnight. There will 5 visits comprising Baseline and two visits for each of the 2 lens designs (Fitting and Assessment). 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. syndrome Questionnaire. In between Fitting and Assessment visits, participants will complete a subjective ratings of vision take home questionnaire utilizing a 1-10 numeric rating scale. A minimum 2-day wash-out will be observed between Fitting and Assessment visits 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 return all unused contact lenses.
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