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The objective of the study is to determine if habitual or adapted contact lens wearers of Omafilcon A can be confidently refit into Somofilcon A lenses and be successful after one week of daily wear.
The primary outcome variables for this study are:
This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, with the test lens (Somofilcon A) being worn for 7 (+5) days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somofilcon A 1-day soft contact lenses | Experimental | Habitual and refitted wearers of omafilcon A were refit into somofilcon A for a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A | Device | contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | 1 week |
| Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | 1 week |
| Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | 1 week |
| Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | 1 week |
| Lens Fit - Post-blink Lens Movement | Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement. | Dispense and 1 Week |
| Lens Fit - Lens Tightness |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Contact Lens Research, University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants | Habitual and refitted wearers of Omafilcon A were refitted with Somofilcon A |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two participants were habitual wearers of omafilcon A; the remaining participants were habitual wearers of other lens types. 71 subjects completed the study and 69 were included in analysis. One participant was excluded from all analysis due to protocol deviation and one participant was excluded from all analysis due to an adverse event.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Habitual and refitted wearers of omafilcon A were refitted with somofilcon A. Two participants were habitual wearers of omafilcon A; the remaining participants were habitual wearers of other lens types. One participant was excluded from all analysis due to protocol deviation and one participant was excluded from all analysis due to an adverse event. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Investigator level of agreement using a Likert scale on refitting participants from omafilcon A to somofilcon A at Visit 1 (Strongly Agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A). | Posted | Count of Participants | Participants | 1 week |
|
From dispense to completion of follow up, approximately one week for each lens, two weeks total.
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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 | Somofilcon A | Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day. Two participants were habitual wearers of Proclear 1 day; the remaining were habitual wearers of other lens types. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega OD MSc FAAO | CooperVision | (925) 621- 3761 | javega@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 4, 2017 | Aug 27, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| omafilcon A |
| Device |
contact lens |
|
Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight. |
| Dispense and 1 week |
| Lens Fit - Lens Deposition | Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface. | Dispense and 1 week |
| Lens Fit - Centration | (3 point scale: optimum, decentration acceptable, decentration unacceptable) | Dispense and 1 Week |
| Lens Fit - Lens Wettability | Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced. | Dispense and 1 Week |
| Overall Lens Fit Acceptance | Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less | Dispense and 1 Week |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Investigator Assessment to Refit- Based on the Investigator Opinion and Lens Fit Outcomes, Would the Investigator Refit the Subject Into Somofilcon A From Omafilcon A? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A). | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Primary | Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A). | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Primary | Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Investigator level of agreement on the ease of refitting participants from omafilcon A to somofilcon A using Likert scale (Strongly agree, Agree, Slightly Agree, Slightly Disagree, Disagree, Strongly Disagree) | Though 71 participants completed all protocol visits, two are completely excluded from all analyses. One participant was excluded because of three protocol deviations and other Participant was excluded because of an adverse event (non-significant ocular from Omafilcon A). | Posted | Count of Participants | Participants | 1 week |
|
|
|
| Primary | Lens Fit - Post-blink Lens Movement | Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement. | 71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis | Posted | Mean | Standard Deviation | units on a scale | Dispense and 1 Week |
|
|
|
| Primary | Lens Fit - Lens Tightness | Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight. | 71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis | Posted | Mean | Standard Deviation | units on a scale | Dispense and 1 week |
|
|
|
| Primary | Lens Fit - Lens Deposition | Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface. | 71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis | Posted | Mean | Standard Deviation | units on a scale | Dispense and 1 week |
|
|
|
| Primary | Lens Fit - Centration | (3 point scale: optimum, decentration acceptable, decentration unacceptable) | 71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis | Posted | Count of Participants | Participants | Dispense and 1 Week |
|
|
|
| Primary | Lens Fit - Lens Wettability | Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced. | 71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis | Posted | Mean | Standard Deviation | units on a scale | Dispense and 1 Week |
|
|
|
| Primary | Overall Lens Fit Acceptance | Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less | 71 participants completed all protocol visits, two are completely excluded from all analyses because of protocol deviations and adverse event.Two participants were habitual wearers of omafilcon A lenses and not necessary to dispense new lenses.They are not included in the omafilcon A dispense analysis but included in the omafilcon A 1-week analysis | Posted | Mean | Standard Deviation | units on a scale | Dispense and 1 Week |
|
|
|
| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Omafilcon A | Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day. Two participants were habitual wearers of Proclear 1 day; the remaining were habitual wearers of other lens types. | 0 | 71 | 0 | 71 | 0 | 71 |
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| Title | Measurements |
|---|---|
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| Slightly agree |
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| Agree |
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| Strongly agree |
|
| Title | Measurements |
|---|---|
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| Sligtly agree |
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| Agree |
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| Strongly Agree |
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| Title | Measurements |
|---|---|
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| Slightly agree |
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| Agree |
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| Strongly agree |
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| 1-week |
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| 1-week |
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| 1-week |
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| Acceptable |
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| Unacceptable |
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| 1-week |
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| 1-week |
|
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| 1-week |
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