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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Presbyope group | Other | 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. |
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| Non-Presbyope group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etafilcon A | Device | Prototype lens material |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 1 week after lens fitting |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Sha, BOptom/BSc | Brien Holden Vision Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brien Holden Vision Institute | Sydney | New South Wales | 2052 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30907859 | Derived | Jong M, Tilia D, Sha J, Diec J, Thomas V, Bakaraju RC. The Relationship between Visual Acuity, Subjective Vision, and Willingness to Purchase Simultaneous-image Contact Lenses. Optom Vis Sci. 2019 Apr;96(4):283-290. doi: 10.1097/OPX.0000000000001359. | |
| 30451806 | Derived | Sha J, Tilia D, Kho D, Amrizal H, Diec J, Yeotikar N, Jong M, Thomas V, Bakaraju RC. Visual Performance of Daily-disposable Multifocal Soft Contact Lenses: A Randomized, Double-blind Clinical Trial. Optom Vis Sci. 2018 Dec;95(12):1096-1104. doi: 10.1097/OPX.0000000000001311. |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Etafilcon A |
| Device |
Control lens for presbyope group |
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| Nelfilcon A | Device | Control lens for presbyope group |
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| Nesofilcon A | Device | Control lens for presbyope group |
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| Nelfilcon A | Device | Control lens for non-presbyope group |
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| Etafilcon A | Device | Control lens for non-presbyope group |
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| Somofilcon A | Device | Control lens for presbyope group |
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| 58% Poly-HEMA | Device | Control lens for presbyope group |
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| Omafilcon A | Device | Control lens for non-presbyope group |
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| Approximately 1 week after lens fitting |