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The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.
This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etafilcon A (control) | Active Comparator | Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye. |
|
| Somofilcon A (test) | Active Comparator | Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etafilcon A (control) | Device | contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever. | 8 hours |
| Comfort Preference | Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens | Baseline and 8 hours |
| Bulbar Hyperemia | Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe. | Baseline and 8 hours |
| Limbal Hyperemia | Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe. | Baseline and 8 hours |
| Conjunctival Staining | Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central | 8 hours |
| Visual Acuity | High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart. | Baseline and 8 hours |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
Is participating in any concurrent clinical or research study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;
Is aphakic;
Has undergone refractive error surgery.
Has participated in the previous somfofilcon A study (ORE# 20893)
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD, FCOptom | Centre for Contact Lens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada | ||
| University of Waterloo |
Of the 103 enrolled, 13 participants were not eligible due to screen failure. This reporting group includes 90 participants (180 eyes) belonging to 2 groups of 45 habitual wearers of either etafilcon A lens or frequent replacement lenses (FREQ). All participants were randomized to wear etafilcon A in one eye and somofilcon A in the fellow eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | Habitual Etafilcon A Wearers | Habitual wearers of etafilcon A were randomized to wear etafilcon A lens in one eye and somofilcon A lens in the other eye for 8 hours during the contralateral study |
| FG001 | Habitual FREQ Wearers | Habitual wearers of other frequent replacement lenses (FREQ) were randomized to wear etafilcon A lens in one eye and somofilcon A lens in the other eye for 8 hours during the contralateral study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Habitual Etafilcon A Wearers Wearing Etafilcon A/Somofilcon A | Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design for 8 hours during the study. |
| BG001 | Habitual FREQ Wearers Wearing Etafilcon A/Somofilcon A |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comfort | Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever. | Posted | Mean | Standard Deviation | units on a scale | 8 hours | eyes | eyes |
|
8 hours
Adverse events will be monitored for during the follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etafilcon A Lens (Control) Worn by Habitual Etafilcon A Grp | Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Global Medical Scientific Affairs | CooperVision Inc. | 925 621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| somofilcon A (test) |
| Device |
contact lens |
|
| Waterloo |
| Canada |
Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design for 8 hours during the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Habitual FREQ Wearers Randomized to Etafilcon A | Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. etafilcon A (control): contact lens |
| OG003 | Habitual FREQ Wearers Randomized to Somofilcon A | Habitual wearers frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. somofilcon A (test): contact lens |
|
|
| Primary | Comfort Preference | Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens | Posted | Number | participants | Baseline and 8 hours |
|
|
|
| Primary | Bulbar Hyperemia | Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 hours | eyes | eyes |
|
|
|
| Primary | Limbal Hyperemia | Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 8 hours | eyes | eyes |
|
|
|
| Primary | Conjunctival Staining | Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central | Posted | Mean | Standard Deviation | units on a scale | 8 hours | eyes | eyes |
|
|
|
| Primary | Visual Acuity | High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart. | Posted | Mean | Standard Deviation | LogMAR | Baseline and 8 hours | eyes | eyes |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Somofilcon A Lens (Test) Worn by Habitual Etafilcon A Grp | Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. | 0 | 45 | 0 | 45 |
| EG002 | Etafilcon A Lens (Control) Worn by Habitual FREQ Grp | Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. | 0 | 45 | 0 | 45 |
| EG003 | Somofilcon A Lens (Test) Worn by Habitual FREQ Grp | Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design. | 0 | 45 | 0 | 45 |
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| Slightly Prefer Etafilcon A Lens |
|
| No Preference |
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| Slightly Prefer Somofilcon A Lens |
|
| Strongly Prefer Somofilcon A Lens |
|
| eyes |
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| 8 hours |
|
| eyes |
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| 8 hours |
|
| eyes |
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| Temporal |
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| Superior |
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| Inferior |
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| eyes |
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| 8 hours |
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