Brien Holden Vision Institue, Clinical Research Trials Center
Sydney, New South Wales, 2052, Australia
NCT Number: NCT02214797
The aim of this study is to assess visual performance of prototype soft contact lens designs compared to commercially available contact lenses over one-week of lens wear.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Sydney, New South Wales, 2052, Australia
Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up to 4 test lens designs will be assessed against the control/s in each parallel arm in a randomized cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Control lenses, Non-presbyopic group, Brand name: Air Optix® Aqua , Acuvue® 1-Day Moist, Lens material: Lotrafilcon B , Etafilcon A, Presbyopic group, Brand name: Air Optix® Multifocal, Acuvue® Oasys for Presbyopia, Lens material Lotrafilcon B, Senofilcon A, Test lens, Brand name: Iteration X, Lens material: Etafilcon A
Time frame: after about 20 minutes of lens wear and after about 1 week of lens wear
Visual Acuity Visual acuity will be recorded on an interval scale. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Visual acuity will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens types will be determined at each time point and over time for each lens type. Visual acuity will be analysed using linear mixed model with subject random intercepts and / or paired t-test.
Time frame: After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear
Subjective ratings Questionnaire Subjective ratings will be recorded on a scale of 1 to 10 on steps of 1. Data will be summarised as means ± standard deviations. No transformation is likely to be required. Subjective ratings will be compared between test and control lens types and time across 1 week. Interactions will be tested and, if present, the significance of lens type will be determined at each time point and over time for each lens type. Subjective ratings will be analysed using linear mixed model with subject random intercepts and / or paired t-test.
Brien Holden Vision
Industry
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