Trial Outcomes & Findings for Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks (NCT NCT02670473)

Results Overview

Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline, 1 week, 2 weeks, and 4 weeks

Results posted on

2018-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Participants Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. fanfilcon A (test): contact lens
Overall Study STARTED	35
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Participants Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. fanfilcon A (test): contact lens
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=34 Participants Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens. fanfilcon A (test): contact lens
Age, Continuous	24.15 years STANDARD_DEVIATION 5.53 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Lens Fit - Centration Optimum	88 percentage of eyes	97 percentage of eyes	99 percentage of eyes	100 percentage of eyes
Lens Fit - Centration Decentration acceptable	12 percentage of eyes	3 percentage of eyes	1 percentage of eyes	0 percentage of eyes
Lens Fit - Centration Decentration unacceptable	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes

PRIMARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Lens Fit - Post-blink Movement Insufficient, unacceptable movement	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Lens Fit - Post-blink Movement Minimal, but acceptable movement	1 percentage of eyes	1 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Lens Fit - Post-blink Movement Optimal movement	35 percentage of eyes	3 percentage of eyes	6 percentage of eyes	18 percentage of eyes
Lens Fit - Post-blink Movement Excessive, unacceptable movement	0 percentage of eyes	0 percentage of eyes	3 percentage of eyes	3 percentage of eyes
Lens Fit - Post-blink Movement Moderate, but acceptable movement	64 percentage of eyes	96 percentage of eyes	91 percentage of eyes	79 percentage of eyes

PRIMARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Lens Tightness on Push-up	50 percentage of lens tightness Standard Deviation 5	49 percentage of lens tightness Standard Deviation 2	50 percentage of lens tightness Standard Deviation 3	50 percentage of lens tightness Standard Deviation 3

PRIMARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Overall Fit Acceptance Borderline but unacceptable	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Overall Fit Acceptance Minimum acceptable	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Overall Fit Acceptance Not perfect but okay	9 percentage of eyes	0 percentage of eyes	7 percentage of eyes	3 percentage of eyes
Overall Fit Acceptance Perfect	91 percentage of eyes	100 percentage of eyes	93 percentage of eyes	97 percentage of eyes
Overall Fit Acceptance Should not be worn	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Overall Comfort	8.03 units on a scale Standard Deviation 0.97	8.91 units on a scale Standard Deviation 1.06	8.97 units on a scale Standard Deviation 0.83	8.85 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Dryness Overall	7.88 units on a scale Standard Deviation 1.32	8.82 units on a scale Standard Deviation 1.09	8.85 units on a scale Standard Deviation 1.08	8.82 units on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Handling	8.85 units on a scale Standard Deviation 1.37	9.26 units on a scale Standard Deviation 1.16	9.59 units on a scale Standard Deviation 0.78	9.62 units on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Overall Vision Satisfaction	9.24 units on a scale Standard Deviation 0.82	9.56 units on a scale Standard Deviation 0.79	9.79 units on a scale Standard Deviation 0.41	9.74 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Population: One participant withdrew from the study after week 1.

Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=35 Participants fanfilcon A lens (test)
Overall Satisfaction Baseline - enfilcon A habitual lens (control)	26 percentage of subjects	71 percentage of subjects	3 percentage of subjects	0 percentage of subjects
Overall Satisfaction 1 week - fanfilcon A lens (test)	53 percentage of subjects	47 percentage of subjects	0 percentage of subjects	0 percentage of subjects
Overall Satisfaction 2 weeks - fanfilcon A lens (test)	65 percentage of subjects	35 percentage of subjects	0 percentage of subjects	0 percentage of subjects
Overall Satisfaction 4 weeks - fanfilcon A lens (test)	71 percentage of subjects	29 percentage of subjects	0 percentage of subjects	0 percentage of subjects

SECONDARY outcome

Timeframe: 1 week, 2 weeks, and 4 weeks

Population: One participant withdrew from the study after week 1.

Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks fanfilcon A lens (test)	Fanfilcon A: 4 Weeks fanfilcon A lens (test)
Lens Preference Overall 1 week	18 percentage of subjects	82 percentage of subjects	—	—
Lens Preference Overall 2 weeks	6 percentage of subjects	94 percentage of subjects	—	—
Lens Preference Overall 4 weeks	6 percentage of subjects	94 percentage of subjects	—	—

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Wearing Times Average wearing time	8.79 hours Standard Deviation 1.67	9.82 hours Standard Deviation 2.11	9.65 hours Standard Deviation 1.69	9.85 hours Standard Deviation 1.56
Wearing Times Comfortable wearing time	7.65 hours Standard Deviation 1.50	8.97 hours Standard Deviation 2.44	8.91 hours Standard Deviation 1.73	8.97 hours Standard Deviation 1.40

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Conjunctival Staining 0	100 percentage of eyes	97 percentage of eyes	99 percentage of eyes	94 percentage of eyes
Conjunctival Staining 0.5	0 percentage of eyes	3 percentage of eyes	1 percentage of eyes	6 percentage of eyes
Conjunctival Staining 1.0	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Conjunctival Staining 1.5	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Conjunctival Staining 2.0	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Conjunctival Staining 2.5	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Conjunctival Staining 3.0	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Conjunctival Staining 3.5	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Conjunctival Staining 4.0	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes

SECONDARY outcome

Timeframe: Baseline, 1 week, 2 weeks, and 4 weeks

Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.

Outcome measures

Outcome measures
Measure	Habitual Lenses: Baseline n=35 Participants enfilcon A habitual lens (control)	Fanfilcon A: 1 Week n=35 Participants fanfilcon A lens (test)	Fanfilcon A: 2 Weeks n=34 Participants fanfilcon A lens (test)	Fanfilcon A: 4 Weeks n=34 Participants fanfilcon A lens (test)
Corneal Staining 1.5	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Corneal Staining 4.0	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Corneal Staining 0	100 percentage of eyes	100 percentage of eyes	100 percentage of eyes	100 percentage of eyes
Corneal Staining 0.5	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Corneal Staining 1.0	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Corneal Staining 2.0	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Corneal Staining 2.5	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Corneal Staining 3.0	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes
Corneal Staining 3.5	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes	0 percentage of eyes

Adverse Events

Overall Participants

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

Senior Manager Global Medical Scientific Affairs

CooperVision Inc.

Phone: 925 621-3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER