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The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Somofilcon A multifocal lens | Experimental | Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A multifocal lens | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vision Clarity During the Day - Distance Vision | Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3 | Baseline |
| Vision Clarity During the Day - Distance Vision | Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3 | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Lens Centration | Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm)) | Baseline |
| Number of Participants With Lens Centration |
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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 | Somofilcon A Multifocal Lens | Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. somofilcon A multifocal lens: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Fifty-one participants were enrolled in the study. Habitual wearers of multifocal soft contact lenses were refit with clariti 1day multifocal. 48 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Total Participants |
| 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 | Vision Clarity During the Day - Distance Vision | Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3 | Posted | Number | percentage of participants | Baseline |
|
From baseline visit of habitual lens through follow up visit of somofilcon A multifocal lens for an average of 3 weeks
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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 Multifocal Lens | Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. somofilcon A multifocal lens: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc., FAAO | CooperVision.Inc | 9256213761 | 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 | Jun 4, 2018 | Nov 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))
| 3 weeks |
| Visual Acuity | Distance visual acuity (logMAR) | Baseline |
| Visual Acuity | Distance visual acuity (logMAR) | 3 weeks |
| Post-blink Lens Movement | Movement of lens on eye after blink was graded on a 5-point Likert scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable, and 4 - excessive unacceptable movement. | Baseline |
| Post-blink Lens Movement | Movement of lens on eye after blink was graded on a 5-point scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable , and 4 - excessive unacceptable. | 3 weeks |
| Corneal Staining | Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central. | Baseline |
| Corneal Staining | Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central. | 3 weeks |
| Conjunctival Staining | Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior. | Baseline |
| Conjunctival Staining | Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentationfor following regions: Temporal, Superior, Nasal, Inferior. | 3 weeks |
| Bulbar Hyperemia | Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. | Baseline |
| Bulbar Hyperemia | Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. | 3 weeks |
| Subjective Vision Satisfaction - Driving at Night | Subjective satisfaction of distance vision while driving at night responses for habitual lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation) | Baseline |
| Subjective Vision Satisfaction - Driving at Night | Subjective satisfaction of distance vision while driving at night responses for somofilcon A multifocal lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation) | 3 weeks |
| Subjective Vision Satisfaction - Long Intermediate Vision | Subjective satisfaction of long intermediate vision while using desktop computer for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation) | Baseline |
| Subjective Vision Satisfaction - Long Intermediate Vision | Subjective satisfaction of long intermediate vision while using desktop computer for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation) | 3 weeks |
| Subjective Vision Satisfaction - Short Intermediate Tasks | Subjective satisfaction of short/intermediate vision while using laptop/tablet for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation) | Baseline |
| Subjective Vision Satisfaction - Short Intermediate Tasks | Subjective satisfaction of short/intermediate vision while using laptop/tablet for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation) | 3 weeks |
| Subjective Vision Satisfaction - Near Vision | Subjective satisfaction of near vision while reading on cell phone and hand-held materials for habitual lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation) | Baseline |
| Subjective Vision Satisfaction - Near Vision | Subjective satisfaction of near vision while reading on cell phone and hand-held materials for somofilcon A multifocal lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation) | 3 weeks |
| Ease of Insertion | Subjective rating how easy lens was inserted on eye for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Baseline |
| Ease of Insertion | Subjective rating how easy lens was inserted on eye for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | 3 weeks |
| Ease of Removal | Subjective rating for habitual lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Baseline |
| Ease of Removal | Subjective rating for somofilcon A multifocal lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | 3 weeks |
| Overall Satisfaction With Speed of Changing Focus | Subjective rating for speed and ability to change focus between distances for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Baseline |
| Overall Satisfaction With Speed of Changing Focus | Subjective rating for speed and ability to change focus between distances for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | 3 weeks |
| Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation) | Baseline |
| Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations)) | 3 weeks |
| Overall Comfort | Subjective rating of comfort for habitual lens and somofilcon A multifocal lens at 3 weeks (Prefer my own strongly, Prefer my own slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly) | 3 weeks |
| Overall Preference Between Study and Habitual Contact Lenses for Lifestyle | Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly) | 3 weeks |
| 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 |
|
| OG002 | Habitual Lens - Distance Tasks in General | Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Contact Lens: Habitual Lens |
|
|
| Primary | Vision Clarity During the Day - Distance Vision | Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3 | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Number of Participants With Lens Centration | Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm)) | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Number of Participants With Lens Centration | Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm)) | Posted | Count of Participants | Participants | 3 weeks |
|
|
|
| Secondary | Visual Acuity | Distance visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMar | Baseline |
|
|
|
| Secondary | Visual Acuity | Distance visual acuity (logMAR) | Posted | Mean | Standard Deviation | logMar | 3 weeks |
|
|
|
| Secondary | Post-blink Lens Movement | Movement of lens on eye after blink was graded on a 5-point Likert scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable, and 4 - excessive unacceptable movement. | Posted | Number | percentage of particpants | Baseline |
|
|
|
| Secondary | Post-blink Lens Movement | Movement of lens on eye after blink was graded on a 5-point scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable , and 4 - excessive unacceptable. | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Corneal Staining | Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central. | Posted | Median | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Corneal Staining | Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central. | Posted | Median | Standard Deviation | units on a scale | 3 weeks |
|
|
|
| Secondary | Conjunctival Staining | Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Conjunctival Staining | Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentationfor following regions: Temporal, Superior, Nasal, Inferior. | Posted | Mean | Standard Deviation | units on a scale | 3 weeks |
|
|
|
| Secondary | Bulbar Hyperemia | Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Bulbar Hyperemia | Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. | Posted | Mean | Standard Deviation | units on a scale | 3 weeks |
|
|
|
| Secondary | Subjective Vision Satisfaction - Driving at Night | Subjective satisfaction of distance vision while driving at night responses for habitual lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Subjective Vision Satisfaction - Driving at Night | Subjective satisfaction of distance vision while driving at night responses for somofilcon A multifocal lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation) | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Subjective Vision Satisfaction - Long Intermediate Vision | Subjective satisfaction of long intermediate vision while using desktop computer for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Subjective Vision Satisfaction - Long Intermediate Vision | Subjective satisfaction of long intermediate vision while using desktop computer for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation) | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Subjective Vision Satisfaction - Short Intermediate Tasks | Subjective satisfaction of short/intermediate vision while using laptop/tablet for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Subjective Vision Satisfaction - Short Intermediate Tasks | Subjective satisfaction of short/intermediate vision while using laptop/tablet for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation) | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Subjective Vision Satisfaction - Near Vision | Subjective satisfaction of near vision while reading on cell phone and hand-held materials for habitual lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Subjective Vision Satisfaction - Near Vision | Subjective satisfaction of near vision while reading on cell phone and hand-held materials for somofilcon A multifocal lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation) | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Ease of Insertion | Subjective rating how easy lens was inserted on eye for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Ease of Insertion | Subjective rating how easy lens was inserted on eye for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Posted | Number | percentage of participants | 3 weeks |
|
|
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| Secondary | Ease of Removal | Subjective rating for habitual lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Ease of Removal | Subjective rating for somofilcon A multifocal lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Overall Satisfaction With Speed of Changing Focus | Subjective rating for speed and ability to change focus between distances for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Overall Satisfaction With Speed of Changing Focus | Subjective rating for speed and ability to change focus between distances for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations) | Posted | Number | percentage of participants | 3 weeks |
|
|
|
| Secondary | Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation) | Posted | Number | percentage of participants | Baseline |
|
|
|
| Secondary | Overall Satisfaction Preference Between Study and Habitual Contact Lenses | Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations)) | Posted | Number | percentage of participants | 3 weeks |
|
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| Secondary | Overall Comfort | Subjective rating of comfort for habitual lens and somofilcon A multifocal lens at 3 weeks (Prefer my own strongly, Prefer my own slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly) | Posted | Number | percentage of participants | 3 weeks |
|
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| Secondary | Overall Preference Between Study and Habitual Contact Lenses for Lifestyle | Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly) | Posted | Number | percentage of participants | 3 weeks |
|
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| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
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| Exceeded my expectations |
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| Unacceptable decentration |
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| Optimal Movement |
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| Moderate, but acceptable Movement |
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| Excessive unacceptable |
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| Title | Measurements |
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| Moderate, but acceptable Movement |
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| Excessive unacceptable |
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| Inferior |
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| Central |
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| Inferior |
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| Central |
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| Inferior |
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| Inferior |
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| Prefer study lenses slightly |
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| Prefer study lenses strongly |
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| Title | Measurements |
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| Prefer study lenses slightly |
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| Prefer study lenses strongly |
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