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The aim of this study is to assess the visual performance of prototype soft contact lens designs compared to a commercially available contact lens
Prospective, participant-masked, randomised, stratified, crossover, bilateral wear, dispensing clinical trial where participants will wear the prototype (test) and the commercial (control) lens. A minimum of an overnight washout period is required between the fitting /assessment visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-presbyopic group | Other | Non-presbyopic group: age ranging from 7 to 39 years At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue 1- Day Moist, etafilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit. For each fitting visit, lenses will be fitted bilaterally. |
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| Presbyopic group | Other | Presbyopic group: age 40 and above At each scheduled lens fitting visit, subjects will be allocated one pair of CLs to correct their refractive error. One pair of control (Acuvue Oasys for Presbyopia, senofilcon A) or prototype (Iteration X, etafilcon A) CLs will be allocated for each lens fitting/assessment visit. Lenses will be worn for approximately 1 hour per visit. For each fitting visit, lenses will be fitted bilaterally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etafilcon A, Senofilcon A | Device | 1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual performance | Visual acuity | After about 20 minutes of lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective responses | Subjective ratings of vision | After about 40 minutes of lens wear |
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Inclusion Criteria:
Exclusion Criteria:
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.
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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 Institute, Clinical Research Trials Center | Sydney | New South Wales | 2052 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16580247 | Background | Morgan PB, Efron N. A decade of contact lens prescribing trends in the United Kingdom (1996-2005). Cont Lens Anterior Eye. 2006 May;29(2):59-68. doi: 10.1016/j.clae.2006.02.008. Epub 2006 Mar 31. | |
| 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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| 21276616 | Background | Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia progression in children. Ophthalmology. 2011 Jun;118(6):1152-61. doi: 10.1016/j.ophtha.2010.10.035. Epub 2011 Jan 26. |
| 22039230 | Background | Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260. |