Myopia
Conditions
Brief summary
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: * Investigator responses to refit questions; * Lens fit.
Detailed description
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.
Interventions
DEVICEsomofilcon A
contact lens
DEVICEomafilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Is at least 17 years of age and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Habitually wears soft spherical contact lenses with a power between +6.00 to -10.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day; * Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses; * Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses; * Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each eye) with the study lenses or habitual correction; * Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye.
Exclusion criteria
* Is participating in any concurrent clinical 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 pharmaceuticals to be used in the study; * Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal communication); * Is aphakic; * Has undergone refractive error surgery; * Is an employee of the Centre for Contact Lens Research; * Has taken part in another clinical or (pharmaceutical) research study within the last 7 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | 1 week | 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) |
| 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? | 1 week | 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) |
| Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | 1 week | 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) |
| Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | 1 week | 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) |
| Lens Fit - Post-blink Lens Movement | Dispense and 1 Week | Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement. |
| Lens Fit - Lens Tightness | Dispense and 1 week | Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight. |
| Lens Fit - Lens Deposition | Dispense and 1 week | Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film \>75% surface. |
| Lens Fit - Centration | Dispense and 1 Week | (3 point scale: optimum, decentration acceptable, decentration unacceptable) |
| Lens Fit - Lens Wettability | Dispense and 1 Week | Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced. |
| Overall Lens Fit Acceptance | Dispense and 1 Week | Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Failure | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Overall Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 71 Participants | — |
| Age, Continuous | 25.3 years STANDARD_DEVIATION 7.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 71 participants | — |
| Sex: Female, Male Female | 52 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 71 |
| other Total, other adverse events | 0 / 71 | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 | 0 / 71 |
Outcome results
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)
Time frame: 1 week
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Participants | 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? | Strongly disagree | 0 Participants |
| Overall Participants | 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? | Disagree | 2 Participants |
| Overall Participants | 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? | Slightly disagree | 18 Participants |
| Overall Participants | 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? | Slightly agree | 20 Participants |
| Overall Participants | 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? | Agree | 18 Participants |
| Overall Participants | 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? | Strongly agree | 11 Participants |
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)
Time frame: 1 week
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Disagree | 3 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Slightly disagree | 30 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Sligtly agree | 19 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Strongly disagree | 1 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Agree | 14 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? | Strongly Agree | 2 Participants |
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)
Time frame: 1 week
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Strongly Disagree | 1 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Disagree | 2 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Slightly Disagree | 19 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Slightly agree | 22 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Agree | 19 Participants |
| Overall Participants | Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? | Strongly agree | 6 Participants |
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)
Time frame: 1 week
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Participants | Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Strongly disagree | 1 Participants |
| Overall Participants | Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Disagree | 0 Participants |
| Overall Participants | Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Slightly disagree | 13 Participants |
| Overall Participants | Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Slightly Agree | 11 Participants |
| Overall Participants | Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Agree | 32 Participants |
| Overall Participants | Investigator Opinion On Overall Patient Refit From Omafilcon A to Somofilcon A: Does Somofilcon A Provides Easy and Quick Refit From Omafilcon A? | Styrongly agree | 12 Participants |
Primary
Lens Fit - Centration
(3 point scale: optimum, decentration acceptable, decentration unacceptable)
Time frame: Dispense and 1 Week
Population: 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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Overall Participants | Lens Fit - Centration | Dispense | Optimum | 26 Participants |
| Overall Participants | Lens Fit - Centration | Dispense | Acceptable | 43 Participants |
| Overall Participants | Lens Fit - Centration | Dispense | Unacceptable | 0 Participants |
| Overall Participants | Lens Fit - Centration | 1-week | Optimum | 28 Participants |
| Overall Participants | Lens Fit - Centration | 1-week | Acceptable | 41 Participants |
| Overall Participants | Lens Fit - Centration | 1-week | Unacceptable | 0 Participants |
| Omafilcon A | Lens Fit - Centration | 1-week | Acceptable | 34 Participants |
| Omafilcon A | Lens Fit - Centration | Dispense | Optimum | 40 Participants |
| Omafilcon A | Lens Fit - Centration | 1-week | Optimum | 35 Participants |
| Omafilcon A | Lens Fit - Centration | Dispense | Acceptable | 27 Participants |
| Omafilcon A | Lens Fit - Centration | 1-week | Unacceptable | 0 Participants |
| Omafilcon A | Lens Fit - Centration | Dispense | Unacceptable | 0 Participants |
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.
Time frame: Dispense and 1 week
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | Lens Fit - Lens Deposition | Dispense | 0.38 units on a scale | Standard Deviation 0.54 |
| Overall Participants | Lens Fit - Lens Deposition | 1-week | 0.60 units on a scale | Standard Deviation 0.63 |
| Omafilcon A | Lens Fit - Lens Deposition | Dispense | 0.22 units on a scale | Standard Deviation 0.33 |
| Omafilcon A | Lens Fit - Lens Deposition | 1-week | 0.36 units on a scale | Standard Deviation 0.51 |
Primary
Lens Fit - Lens Tightness
Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.
Time frame: Dispense and 1 week
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | Lens Fit - Lens Tightness | Dispense | 48 units on a scale | Standard Deviation 9 |
| Overall Participants | Lens Fit - Lens Tightness | 1-week | 51 units on a scale | Standard Deviation 8 |
| Omafilcon A | Lens Fit - Lens Tightness | Dispense | 46 units on a scale | Standard Deviation 7 |
| Omafilcon A | Lens Fit - Lens Tightness | 1-week | 47 units on a scale | Standard Deviation 9 |
Primary
Lens Fit - Lens Wettability
Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.
Time frame: Dispense and 1 Week
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | Lens Fit - Lens Wettability | Dispense | 0.54 units on a scale | Standard Deviation 0.66 |
| Overall Participants | Lens Fit - Lens Wettability | 1-week | 0.83 units on a scale | Standard Deviation 0.78 |
| Omafilcon A | Lens Fit - Lens Wettability | Dispense | 0.21 units on a scale | Standard Deviation 0.34 |
| Omafilcon A | Lens Fit - Lens Wettability | 1-week | 0.42 units on a scale | Standard Deviation 0.25 |
Primary
Lens Fit - Post-blink Lens Movement
Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.
Time frame: Dispense and 1 Week
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | Lens Fit - Post-blink Lens Movement | Dispense | 2.1 units on a scale | Standard Deviation 0.5 |
| Overall Participants | Lens Fit - Post-blink Lens Movement | 1-week | 1.9 units on a scale | Standard Deviation 0.6 |
| Omafilcon A | Lens Fit - Post-blink Lens Movement | 1-week | 2.0 units on a scale | Standard Deviation 0.6 |
| Omafilcon A | Lens Fit - Post-blink Lens Movement | Dispense | 2.2 units on a scale | Standard Deviation 0.5 |
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
Time frame: Dispense and 1 Week
Population: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Participants | Overall Lens Fit Acceptance | Dispense | 3.3 units on a scale | Standard Deviation 0.6 |
| Overall Participants | Overall Lens Fit Acceptance | 1-week | 3.2 units on a scale | Standard Deviation 0.7 |
| Omafilcon A | Overall Lens Fit Acceptance | Dispense | 3.6 units on a scale | Standard Deviation 0.5 |
| Omafilcon A | Overall Lens Fit Acceptance | 1-week | 3.4 units on a scale | Standard Deviation 0.7 |