An interventional study of Etafilcon A and Etafilcon A in Presbyopia and Refractive Error, sponsored by Brien Holden Vision. Completed at 1 site in Australia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by Brien Holden Vision · Not applicable, Interventional, and Treatment
The aim of this study is to assess the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.
Prospective, double-masked, crossover, bilateral wear, dispensing clinical trial where participants will wear multiple prototype (test) and commercial (control) lenses.
Multiple prototype contact lens designs will be assessed against commercial control lenses during the study, where each design will be worn for up to a week. There will be a minimum 1 night washout period between lens designs.
324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.
This study's enrollment of 161 is above the median of 61 across 265 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Brien Holden Vision is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40 years and over with a reading add. Control lens: Etafilcon A, Nelfilcon A, Nesofilcon A, Somofilcon A, 58% Poly-HEMA Test lens: Etafilcon A Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by each participant for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.
Device: Etafilcon A · Device: Nelfilcon A · Device: Nesofilcon A · Device: Somofilcon A · Device: 58% Poly-HEMA
18-39 years with no reading add. Control lens: Etafilcon A, Nelfilcon A, Omafilcon A Test lens: Etafilcon A Up to 10 prototype contact lens designs and at least 1 commercially available contact lens designs will be worn by participants for up to a week on a daily disposable modality. Participants will attend separate fitting and assessment visits for each lens type (Fitting Visit on Day 1, and Assessment Visit as late as Day 7, but may be as early as 6 hours after the Fitting Visit). There will be a minimum 1 night washout period between lens designs, i.e. after an assessment visit but before the next fitting visit.
Device: Etafilcon A · Device: Nelfilcon A · Device: Omafilcon A
Prototype lens material
Control lens for presbyope group
Also known as: 1-Day Acuvue Moist Multifocal
Control lens for presbyope group
Also known as: Dailies Aqua Comfort Plus Multifocal
Control lens for presbyope group
Also known as: Biotrue ONEday for Presbyopia
Control lens for non-presbyope group
Also known as: Dailies Aqua Comfort Plus
Control lens for non-presbyope group
Also known as: 1-Day Acuvue Moist
Control lens for presbyope group
Also known as: Clariti 1 Day Multifocal
Control lens for presbyope group
Also known as: SEED 1dayPure moisture Multistage
Control lens for non-presbyope group
Also known as: Proclear Multifocal
Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale
For each lens, visual acuity will be measured at distance with a computerised LogMAR chart and at near with a near LogMAR chart. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Visual acuity will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of visual acuity. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.
Time frame: Approximately 1 week after lens fitting
Subjective rating of vision on a 1-10 visual analogue scale
For each lens, subjective ratings of vision will be assessed with a questionnaire based on a 1 to 10 scale in steps of 1. The questionnaire has been designed specifically for this study. Data will be summarised as means +/- standard deviations. No transformation is likely to be required. Subjective ratings will be compared between each lens design and control lens types. The significance of lens design will be determined for each visit. Repeated effects linear mixed model with subject random intercepts or paired t tests will be employed for the analysis of subjective ratings. Analysis will be performed within each study arm namely presbyopes and non-presbyopes.
Time frame: Approximately 1 week after lens fitting
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Brien Holden Vision