Trial Outcomes & Findings for Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses (NCT NCT02956460)

NCT ID: NCT02956460

Last Updated: 2018-04-02

Results Overview

Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2018-04-02

Participant Flow

Participant milestones

Measure	Fanfilcon A First Then Senofilcon A Participants are randomized to wear fanfilcon A for two weeks then senofilcon A	Senofilcon A First Then Fanfilcon A Participants are randomized to wear senofilcon A for two weeks then fanfilcon A
Lens 1 STARTED	30	34
Lens 1 COMPLETED	29	34
Lens 1 NOT COMPLETED	1	0
Lens 2 STARTED	29	34
Lens 2 COMPLETED	29	34
Lens 2 NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Fanfilcon A First Then Senofilcon A Participants are randomized to wear fanfilcon A for two weeks then senofilcon A	Senofilcon A First Then Fanfilcon A Participants are randomized to wear senofilcon A for two weeks then fanfilcon A
Lens 1 Lost to Follow-up	1	0

Baseline Characteristics

Performance Comparison Between Fanfilcon A and Senofilcon A Sphere Lenses

Baseline characteristics by cohort

Measure	Fanfilcon A First Then Senofilcon A n=30 Participants Participants are randomized to wear fanfilcon A for two weeks then senofilcon A	Senofilcon A First Then Fanfilcon A n=34 Participants Participants are randomized to wear senofilcon A for two weeks then fanfilcon A	Total n=64 Participants Total of all reporting groups
Age, Continuous	31.6 years STANDARD_DEVIATION 6.1 • n=5 Participants	29.6 years STANDARD_DEVIATION 5.6 • n=7 Participants	30.5 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	28 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Subjective assessment for comfort is assessed. Scale 0-10, 0=painful, 10=can't feel

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Comfort	8.4 units on a scale Standard Deviation 1.9	8.7 units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for dryness is assessed on a scale of 0-10, 0=extremely dry, 10=no dryness

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Overall Dryness	8.2 units on a scale Standard Deviation 1.9	8.2 units on a scale Standard Deviation 1.9

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings of vision quality is assessed on a scale 0-10, 0=not sharp/not clear, 10=sharp/clear

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Vision Quality	9.0 units on a scale Standard Deviation 1.5	8.9 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings of lens handling - insertion and removal - is assessed using scale 0-10, 0=difficult to handle, 10=very easy to handle

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Lens Handling Insertion	9.3 units on a scale Standard Deviation 1.3	9.4 units on a scale Standard Deviation 1.2
Lens Handling Removal	8.4 units on a scale Standard Deviation 2.0	9.3 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings of vision satisfaction is assessed on a scale 0-10, 0=completely dissatisfied, 10=completely satisfied.

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Vision Satisfaction	8.7 units on a scale Standard Deviation 2.1	8.6 units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 2 weeks

Lens centration will be recorded by degree and direction in the primary position. (Optimum, decentration acceptable, decentration unacceptable).

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Lens Centration Optimum	62 Participants	63 Participants
Lens Centration Acceptable	1 Participants	0 Participants
Lens Centration Unacceptable	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 weeks

Assessed using slit lamp with blue light and sodium fluorescein, low medium magnification.

0=None, no staining present

1. Very slight

2. Slight

3. Moderate

4. Severe

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Conjunctival Staining	0.4 units on a scale Standard Deviation 0.7	0.6 units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for lens sensation of smoothness is assessed on a scale 0-10, 0=not smooth at all, 10=totally smooth

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Smoothness	8.7 units on a scale Standard Deviation 1.7	9.1 units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for lens clean feeling is assessed on a scale 0-10, 0=not clean at all, 10=lenses feel perfectly clean

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Clean Feeling	8.7 units on a scale Standard Deviation 1.7	8.9 units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for lens sensation is assessed on a scale 0-10, 0=totally dehydrated, 10=totally hydrated

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Lens Hydrated	8.3 units on a scale Standard Deviation 2.0	8.5 units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 2 weeks

Subjective ratings for lens wettability is assessed on a scale 0-10, 0=non-wettable, 10=highly wettable

Outcome measures

Measure	Fanfilcon A n=63 Participants Participants are randomized to wear fanfilcon A either first or second for two weeks during the cross over study.	Senofilcon A n=63 Participants Participants are randomized to wear senofilcon A either first or second for two weeks during the cross over study.
Lens Wettability	8.4 units on a scale Standard Deviation 1.9	8.5 units on a scale Standard Deviation 1.6

Adverse Events

Fanfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon 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 Vega, O.D., MSc., FAAO

CooperVision

Phone: 925-621-3761

Email: JVega2@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 use of study data for results communication.
• Publication restrictions are in place

Restriction type: OTHER