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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12614000011684 | Registry Identifier | ANZCTR |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Presbyopic group - Low Add | Other | 40 years and over Add of less than +1.50D Control lens : Lotrafilcon B and Senofilcon A Test lens: Etafilcon A Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised cross over fashion. Each lenses will be worn for a week with a minimum 2 day washout period between the lens types. Each lens will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit. |
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| Presbyopic group - Med Add | Other | 40 years and over Add of +1.50D to +1.75D Control lens : Lotrafilcon B and Senofilcon A Test lens: Etafilcon A Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised 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. |
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| Presbyopic group - High Add | Other | 40 years and over Add of +2.00D to +2.50D Control lens : Lotrafilcon B and Senofilcon A Test lens: Etafilcon A Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised 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. |
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| Non-presbyopic group | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etafilcon A, Lotrafilcon B , Senofilcon A | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in visual performance over 1-week 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. | after about 20 minutes of lens wear and after about 1 week of lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective response over 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Jiyoon Chung, BOptom | Brien Holden Vision Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brien Holden Vision Institue, Clinical Research Trials Center | Sydney | New South Wales | 2052 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12477016 | Background | Young G, Veys J, Pritchard N, Coleman S. A multi-centre study of lapsed contact lens wearers. Ophthalmic Physiol Opt. 2002 Nov;22(6):516-27. doi: 10.1046/j.1475-1313.2002.00066.x. | |
| 18538404 | Background | Stapleton F, Keay L, Edwards K, Naduvilath T, Dart JK, Brian G, Holden BA. The incidence of contact lens-related microbial keratitis in Australia. Ophthalmology. 2008 Oct;115(10):1655-62. doi: 10.1016/j.ophtha.2008.04.002. Epub 2008 Jun 5. |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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18 to 39 years old No Add
Control lens : Lotrafilcon B and Etafilcon A
Test lens: Etafilcon A
Up to 4 test lens designs will be assessed against commercial control/s in each parallel arm in a randomised 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.
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| After about 40 mins of lens wear and after 2 days, 4 days and 1 week of lens wear |
| 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. |