Trial Outcomes & Findings for Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses (NCT NCT03519932)

NCT ID: NCT03519932

Last Updated: 2020-01-06

Results Overview

Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: Dispense
• Results posted on: 2020-01-06

Participant Flow

Subjects were randomized to wear comfilcon A toric lenses for 1-month and samfilcon A toric lenses for 1-month in this cross-over dispensing study.

Participant milestones

Measure	Comfilcon A Toric Then Samfilcon A Toric Subjects were randomized to wear comfilcon A toric lenses for 1-month and then crossover to wear Samfilcon A toric lenses for 1-month. Contact Lens: comfilcon A toric Contact Lens: Samfilcon A toric	Samfilcon A Toric Then Comfilcon A Toric Subjects were randomized to wear sammfilcon A toric lenses for 1-month and then crossover to wear comfilcon A toric lenses for 1-month. Contact Lens: Samfilcon A toric Contact Lens: comfilcon A toric
First Intervention STARTED	24	25
First Intervention COMPLETED	23	22
First Intervention NOT COMPLETED	1	3
Second Intervention STARTED	22	23
Second Intervention COMPLETED	22	23
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Comfilcon A Toric Then Samfilcon A Toric Subjects were randomized to wear comfilcon A toric lenses for 1-month and then crossover to wear Samfilcon A toric lenses for 1-month. Contact Lens: comfilcon A toric Contact Lens: Samfilcon A toric	Samfilcon A Toric Then Comfilcon A Toric Subjects were randomized to wear sammfilcon A toric lenses for 1-month and then crossover to wear comfilcon A toric lenses for 1-month. Contact Lens: Samfilcon A toric Contact Lens: comfilcon A toric
First Intervention Adverse Event	1	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Overall Study n=49 Participants Total Participants
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=49 Participants
Age, Categorical >=65 years	0 Participants n=49 Participants
Age, Continuous	26.5 years STANDARD_DEVIATION 8.7 • n=49 Participants
Sex: Female, Male Female	40 Participants n=49 Participants
Sex: Female, Male Male	9 Participants n=49 Participants
Region of Enrollment Canada	49 participants n=49 Participants

PRIMARY outcome

Timeframe: Dispense

Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

Outcome measures

Measure	Comfilcon A Toric Lens n=45 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Comfort at Insertion	9.0 units on a scale Standard Deviation 1.2	8.8 units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: 2 weeks

Population: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

Outcome measures

Measure	Comfilcon A Toric Lens n=44 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Comfort Overall	8.1 units on a scale Standard Deviation 1.4	7.4 units on a scale Standard Deviation 2.1
Comfort Removal	7.2 units on a scale Standard Deviation 2.1	6.5 units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 1-month

Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)

Outcome measures

Measure	Comfilcon A Toric Lens n=45 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=44 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Comfort Overall	8.1 units on a scale Standard Deviation 1.6	7.4 units on a scale Standard Deviation 2.1
Comfort Removal	7.1 units on a scale Standard Deviation 2.1	6.7 units on a scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 1 month

Population: Percentages may be rounded and therefore may not add up to equal to 100%

Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

Outcome measures

Measure	Comfilcon A Toric Lens n=45 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Lens Preference Based on Overall Comfort Strongly prefer comfilcon A	44 percentage of participants	—
Lens Preference Based on Overall Comfort Slightly Prefer comfilcon A	27 percentage of participants	—
Lens Preference Based on Overall Comfort No Preference	7 percentage of participants	—
Lens Preference Based on Overall Comfort Slightly prefer samfilcon A	7 percentage of participants	—
Lens Preference Based on Overall Comfort Strongly prefer samfilcon A	16 percentage of participants	—

PRIMARY outcome

Timeframe: 1 month

Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)

Outcome measures

Measure	Comfilcon A Toric Lens n=45 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Lens Preference Based on Overall Dryness Strongly prefer comfilcon A	29 percentage of participants	—
Lens Preference Based on Overall Dryness Slightly prefer comfilcon A	33 percentage of participants	—
Lens Preference Based on Overall Dryness No Preference	16 percentage of participants	—
Lens Preference Based on Overall Dryness Slightly prefer samfilcon A	4 percentage of participants	—
Lens Preference Based on Overall Dryness Strongly prefer samfilcon A	18 percentage of participants	—

PRIMARY outcome

Timeframe: 2 weeks

Population: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

Outcome measures

Measure	Comfilcon A Toric Lens n=44 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Dryness Overall	7.4 units on a scale Standard Deviation 2.0	6.9 units on a scale Standard Deviation 2.2
Dryness Removal	6.5 units on a scale Standard Deviation 2.5	6.0 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 1-month

Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)

Outcome measures

Measure	Comfilcon A Toric Lens n=45 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Dryness Overall	7.5 units on a scale Standard Deviation 1.8	6.7 units on a scale Standard Deviation 2.5
Dryness Removal	6.6 units on a scale Standard Deviation 2.3	6.2 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Dispense

Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

Outcome measures

Measure	Comfilcon A Toric Lens n=45 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Ease of Insertion	9.3 units on a scale Standard Deviation 1.0	9.3 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 2-weeks

Population: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

Outcome measures

Measure	Comfilcon A Toric Lens n=44 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Ease of Insertion	8.9 units on a scale Standard Deviation 1.5	8.4 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: 1-month

Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)

Outcome measures

Measure	Comfilcon A Toric Lens n=45 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Ease of Insertion	9.0 units on a scale Standard Deviation 1.4	8.3 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 2-weeks

Population: One subject's subjective rating was excluded for comfilcon A toric due to subject confusion at rating scale and potentially reversing its use.

Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)

Outcome measures

Measure	Comfilcon A Toric Lens n=44 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Ease of Removal	7.9 units on a scale Standard Deviation 2.5	8.4 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 1 month

Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)

Outcome measures

Measure	Comfilcon A Toric Lens n=45 Participants Subjects were randomized to wear comfilcon A toric lens and samfilcon A toric lens during this cross-over study. comfilcon A toric lens: Contact lens	Samfilcon A Toric Lens n=45 Participants Subjects were randomized to wear samfilcon A toric lens and comfilcon A toric lens during this cross-over study. samfilcon A toric lens: Contact lens
Ease of Removal	8.0 units on a scale Standard Deviation 2.4	8.5 units on a scale Standard Deviation 1.7

Adverse Events

Comfilcon A Toric

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Samfilcon A Toric

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 Inc.

Phone: 9256213761

Email: javega@coopervision.com

Results disclosure agreements

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