Trial Outcomes & Findings for Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A (NCT NCT03226353)

NCT ID: NCT03226353

Last Updated: 2019-09-12

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 77 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2019-09-12

Participant Flow

Participant milestones

Measure	Overall Participants Habitual and refitted wearers of Omafilcon A were refitted with Somofilcon A
Overall Study STARTED	77
Overall Study Habitual Wearers of Proclear 1 Day	2
Overall Study Other Habitual Lens Types	75
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Overall Participants Habitual and refitted wearers of Omafilcon A were refitted with Somofilcon A
Overall Study Withdrawal by Subject	1
Overall Study Screen Failure	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Participants n=71 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.
Age, Categorical <=18 years	0 Participants n=71 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=71 Participants
Age, Categorical >=65 years	0 Participants n=71 Participants
Age, Continuous	25.3 years STANDARD_DEVIATION 7.6 • n=71 Participants
Sex: Female, Male Female	52 Participants n=71 Participants
Sex: Female, Male Male	19 Participants n=71 Participants
Region of Enrollment Canada	71 participants n=71 Participants

PRIMARY outcome

Timeframe: 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).

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)

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
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	—
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	—
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	—
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	—
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	—
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 outcome

Timeframe: 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).

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)

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a 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? Strongly disagree	0 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	—
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	—
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	—
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	—
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 outcome

Timeframe: 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).

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)

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? Strongly disagree	1 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? Disagree	3 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? Slightly disagree	30 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? Sligtly agree	19 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? Agree	14 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Performs Better Than Omafilcon A Day? Strongly Agree	2 Participants	—

PRIMARY outcome

Timeframe: 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).

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)

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? Strongly Disagree	1 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? Disagree	2 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? Slightly Disagree	19 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? Slightly agree	22 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? Agree	19 Participants	—
Investigator Assessment to Refit - Does Somofilcon A Provides an Upgrade From Omafilcon A? Strongly agree	6 Participants	—

PRIMARY outcome

Timeframe: 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

Graded on a scale of 0-4, 1 step, 0=Insufficient, unacceptable movement, 4=Excessive, unacceptable movement.

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A n=69 Participants All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Lens Fit - Post-blink Lens Movement Dispense	2.1 units on a scale Standard Deviation 0.5	2.2 units on a scale Standard Deviation 0.5
Lens Fit - Post-blink Lens Movement 1-week	1.9 units on a scale Standard Deviation 0.6	2.0 units on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: 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

Graded using 0-100 scale (5% steps) where 0 = extremely loose and 100 = extremely tight.

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A n=69 Participants All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Lens Fit - Lens Tightness Dispense	48 units on a scale Standard Deviation 9	46 units on a scale Standard Deviation 7
Lens Fit - Lens Tightness 1-week	51 units on a scale Standard Deviation 8	47 units on a scale Standard Deviation 9

PRIMARY outcome

Timeframe: 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

Graded on a scale of 0-4, with 0.25 increments, 0=no deposits; 4=deposit ≥ 0.5mm or film >75% surface.

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A n=69 Participants All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Lens Fit - Lens Deposition 1-week	0.60 units on a scale Standard Deviation 0.63	0.36 units on a scale Standard Deviation 0.51
Lens Fit - Lens Deposition Dispense	0.38 units on a scale Standard Deviation 0.54	0.22 units on a scale Standard Deviation 0.33

PRIMARY outcome

Timeframe: 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

(3 point scale: optimum, decentration acceptable, decentration unacceptable)

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A n=69 Participants All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Lens Fit - Centration Dispense · Optimum	26 Participants	40 Participants
Lens Fit - Centration Dispense · Acceptable	43 Participants	27 Participants
Lens Fit - Centration Dispense · Unacceptable	0 Participants	0 Participants
Lens Fit - Centration 1-week · Optimum	28 Participants	35 Participants
Lens Fit - Centration 1-week · Acceptable	41 Participants	34 Participants
Lens Fit - Centration 1-week · Unacceptable	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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

Graded on a scale of 0-4 with 0.25 increments, 0=excellent; 4=severely reduced.

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A n=69 Participants All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Lens Fit - Lens Wettability Dispense	0.54 units on a scale Standard Deviation 0.66	0.21 units on a scale Standard Deviation 0.34
Lens Fit - Lens Wettability 1-week	0.83 units on a scale Standard Deviation 0.78	0.42 units on a scale Standard Deviation 0.25

PRIMARY outcome

Timeframe: 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

Graded on a 0-4 point scale (where 0 = should not be worn, 4=perfect), providing a reason if Grade 2 or less

Outcome measures

Measure	Overall Participants n=69 Participants Habitual and refitted wearers of Proclear 1 Day were refitted with Clariti 1 Day	Omafilcon A n=69 Participants All participants that habitually wear omafilcon A and other contact lenses are refitted with omafilcon A for a week and then Fitted with somofilcon A for a week.
Overall Lens Fit Acceptance Dispense	3.3 units on a scale Standard Deviation 0.6	3.6 units on a scale Standard Deviation 0.5
Overall Lens Fit Acceptance 1-week	3.2 units on a scale Standard Deviation 0.7	3.4 units on a scale Standard Deviation 0.7

Adverse Events

Somofilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jose A. Vega OD MSc FAAO

CooperVision

Phone: (925) 621- 3761

Email: javega@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place