Trial Outcomes & Findings for Performance Comparison Between Comfilcon A and Senofilcon C Lenses (NCT NCT02920957)

NCT ID: NCT02920957

Last Updated: 2018-01-09

Results Overview

Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 88 participants
• Primary outcome timeframe: Up to 1 month
• Results posted on: 2018-01-09

Participant Flow

There were 88 participants enrolled for this study, with 1 participant failed the screening leading to 87 who were fitted with and dispensed contact lenses.

Participant milestones

Measure	Comfilcon A First Then Senofilcon C Participants randomized to wear the comfilcon A lens first then crossover to Senofilcon C	Senofilcon C First Then Comfilcon A Participants randomized to wear the senofilcon C lens first then crossover to comfilcon A
First Intervention : 1 Month STARTED	46	41
First Intervention : 1 Month COMPLETED	42	41
First Intervention : 1 Month NOT COMPLETED	4	0
Second Intervention: 1 Month STARTED	42	41
Second Intervention: 1 Month COMPLETED	42	40
Second Intervention: 1 Month NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Comfilcon A First Then Senofilcon C Participants randomized to wear the comfilcon A lens first then crossover to Senofilcon C	Senofilcon C First Then Comfilcon A Participants randomized to wear the senofilcon C lens first then crossover to comfilcon A
First Intervention : 1 Month Withdrawal by Subject	2	0
First Intervention : 1 Month Lost to Follow-up	1	0
First Intervention : 1 Month Adverse Event	1	0
Second Intervention: 1 Month Lost to Follow-up	0	1

Baseline Characteristics

Performance Comparison Between Comfilcon A and Senofilcon C Lenses

Baseline characteristics by cohort

Measure	Overall Baseline Characteristics n=87 Participants Includes groups randomized to wear comfilcon A lens first and senofilcon C lens first.
Age, Continuous Age	27.9 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 month

Population: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.

Outcome measures

Measure	Comfilcon A at Dispense n=85 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 2 Weeks n=84 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 1 Month n=82 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Senofilcon C at Dispense n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 2 Weeks n=82 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 1 Month n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens
Overall Lens Fit Acceptance	3.6 units on a scale Standard Deviation 0.5	3.5 units on a scale Standard Deviation 0.6	3.5 units on a scale Standard Deviation 0.7	3.5 units on a scale Standard Deviation 0.7	3.5 units on a scale Standard Deviation 0.6	3.3 units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: Up to 1 month

Population: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)

Outcome measures

Measure	Comfilcon A at Dispense n=85 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 2 Weeks n=84 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 1 Month n=82 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Senofilcon C at Dispense n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 2 Weeks n=82 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 1 Month n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens
Corneal Coverage Yes	85 participants	84 participants	82 participants	83 participants	82 participants	83 participants
Corneal Coverage No	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Up to 1 month

Population: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)

Outcome measures

Measure	Comfilcon A at Dispense n=85 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 2 Weeks n=84 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 1 Month n=82 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Senofilcon C at Dispense n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 2 Weeks n=82 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 1 Month n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens
Lens Centration Optimum	77 participants	78 participants	76 participants	71 participants	71 participants	76 participants
Lens Centration Acceptable	7 participants	6 participants	5 participants	11 participants	10 participants	5 participants
Lens Centration Unacceptable	1 participants	0 participants	1 participants	1 participants	1 participants	2 participants

PRIMARY outcome

Timeframe: Up to 1 month

Population: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)

Outcome measures

Measure	Comfilcon A at Dispense n=85 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 2 Weeks n=84 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 1 Month n=82 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Senofilcon C at Dispense n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 2 Weeks n=82 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 1 Month n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens
Post-blink Movement	1.8 units on a scale Standard Deviation 0.5	1.9 units on a scale Standard Deviation 0.5	1.9 units on a scale Standard Deviation 0.5	1.9 units on a scale Standard Deviation 0.6	1.9 units on a scale Standard Deviation 0.4	1.8 units on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: Up to 1 month

Population: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)

Outcome measures

Measure	Comfilcon A at Dispense n=85 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 2 Weeks n=84 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 1 Month n=82 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Senofilcon C at Dispense n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 2 Weeks n=82 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 1 Month n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens
Lens Lag at Primary Gaze	0.2 millimeters Standard Deviation 0.2	0.2 millimeters Standard Deviation 0.1	0.2 millimeters Standard Deviation 0.1	0.2 millimeters Standard Deviation 0.1	0.2 millimeters Standard Deviation 0.1	0.2 millimeters Standard Deviation 0.1

PRIMARY outcome

Timeframe: Up to 1 month

Population: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)

Outcome measures

Measure	Comfilcon A at Dispense n=85 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 2 Weeks n=84 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 1 Month n=82 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Senofilcon C at Dispense n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 2 Weeks n=82 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 1 Month n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens
Tightness on Push up	54 units on a scale Standard Deviation 10	51 units on a scale Standard Deviation 9	51 units on a scale Standard Deviation 8	54 units on a scale Standard Deviation 9	53 units on a scale Standard Deviation 9	53 units on a scale Standard Deviation 9

PRIMARY outcome

Timeframe: Up to 1 month

Population: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)

Outcome measures

Measure	Comfilcon A at Dispense n=85 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 2 Weeks n=84 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 1 Month n=82 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Senofilcon C at Dispense n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 2 Weeks n=82 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 1 Month n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens
Lens Wettability	3.8 units on a scale Standard Deviation 0.4	3.5 units on a scale Standard Deviation 0.6	3.4 units on a scale Standard Deviation 0.8	3.7 units on a scale Standard Deviation 0.4	3.3 units on a scale Standard Deviation 0.7	3.3 units on a scale Standard Deviation 0.6

PRIMARY outcome

Timeframe: Up to 1 month

Population: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)

Outcome measures

Measure	Comfilcon A at Dispense n=85 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 2 Weeks n=84 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Comfilcon A After 1 Month n=82 Participants Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens	Senofilcon C at Dispense n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 2 Weeks n=82 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens	Senofilcon C After 1 Month n=83 Participants Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens
Deposit Grading	0.0 units on a scale Standard Deviation 0.2	0.3 units on a scale Standard Deviation 0.6	0.5 units on a scale Standard Deviation 0.7	0.1 units on a scale Standard Deviation 0.3	0.4 units on a scale Standard Deviation 0.7	0.7 units on a scale Standard Deviation 0.8

Adverse Events

Comfilcon A

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Comfilcon A n=87 participants at risk Participants are randomized to wear the comfilcon A lens for one month during either as the first or second intervention.	Senofilcon C n=83 participants at risk Participants are randomized to wear the senofilcon C lens for one month during either as the first or second intervention.
Surgical and medical procedures Motocycle Accident	1.1% 1/87 • Number of events 1 Assessment of adverse events was performed during the study visits. Investigators may be notified of adverse events by the participants outside of the study visits.	0.00% 0/83 Assessment of adverse events was performed during the study visits. Investigators may be notified of adverse events by the participants outside of the study visits.

Other adverse events

Adverse event data not reported

Additional Information

Sr.Manager Global Medical Scientific Affairs

CooperVision Inc

Phone: (925) 621-3761

Email: javega@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
• Publication restrictions are in place

Restriction type: OTHER