An interventional study of etafilcon - PVP (multi-focal) in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Basic science
The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)
Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study.
Device: etafilcon - PVP (multi-focal)
The investigational contact lens must be worn at least six hours daily.
Upper Eye Lid Margin Staining
Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\^2.
Time frame: 30 days Post wear
Limbal Staining
Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.
Time frame: 30 Days Post Wear
Corneal Staining
The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.
Time frame: 30 Days Post Wear
| Milestone | Etafilcon PVP (Multi-focal) |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\^2.
| mm^2 | Etafilcon PVP (Multi-focal) |
|---|---|
| Upper Eye Lid Margin Staining | 1.96 ± 1.03 |
Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.
| percentage of limbal area | Etafilcon PVP (Multi-focal) |
|---|---|
| Nasal | 1.03 ± 1.30 |
| Temporal | 0.68 ± 1.38 |
The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.
| percentage of upper corneal quadrant | Etafilcon PVP (Multi-focal) |
|---|---|
| Corneal Staining | 0.05 ± 0.12 |
Collected over Throughout the duration of the study. Approximately 3 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etafilcon PVP (Multi-focal) | — | 0/20 (0%) | 0/20 (0%) |
All subjects that were dispensed a study lens.
| Age, Continuous(Years) | Etafilcon PVP (Multi-focal) |
|---|---|
| Mean | 50.6 ± 6.85 |
| Sex: Female, Male(Participants) | Etafilcon PVP (Multi-focal) |
|---|---|
| Female | 15 |
| Male | 5 |
| Race/Ethnicity, Customized(Participants) | Etafilcon PVP (Multi-focal) |
|---|---|
| Asian | 20 |
| Region of Enrollment(Participants) | Etafilcon PVP (Multi-focal) |
|---|---|
| United Kingdom | 20 |
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Johnson & Johnson Vision Care, Inc.