Trial Outcomes & Findings for Clinical Performance of Stenfilcon A Versus Filcon II 3 (NCT NCT01808209)

NCT ID: NCT01808209

Last Updated: 2020-08-03

Results Overview

Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2020-08-03

Participant Flow

Sixty habitual contact lens wearing subjects were recruited by the Optometry Clinic at Aston University

All subjects were habitual lens wearers and were randomized to each pair of study lenses. Only one patient failed to complete all study visits and their data was excluded from the analysis.

Participant milestones

Measure	Stenfilcon A Then Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.	Filcon II 3 Then Stenfilcon A All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
Overall Study STARTED	33	27
Overall Study COMPLETED	33	26
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Stenfilcon A Then Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.	Filcon II 3 Then Stenfilcon A All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Clinical Performance of Stenfilcon A Versus Filcon II 3

Baseline characteristics by cohort

Measure	Stenfilcon A Then Filcon II 3 n=33 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.	Filcon II 3 Then Stenfilcon A n=26 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	26 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United Kingdom	33 participants n=5 Participants	26 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Daily and Comfortable Wearing Time Average Wearing Time	9.8 hours Standard Deviation 3.1	—
Daily and Comfortable Wearing Time Average Comfortable Wearing Time	7.7 hours Standard Deviation 3.4	—

PRIMARY outcome

Timeframe: 1 week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=59 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Daily and Comfortable Wearing Time Average Wearing Time	11.4 hours Standard Deviation 2.6	10.8 hours Standard Deviation 2.6
Daily and Comfortable Wearing Time Average Comfortable Wearing Time	8.7 hours Standard Deviation 3.0	8.7 hours Standard Deviation 2.8

PRIMARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=59 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Handling From Blister	90.8 units on a scale Standard Deviation 11.7	92.2 units on a scale Standard Deviation 0.32
Handling Inside Out	84.9 units on a scale Standard Deviation 24.6	86.4 units on a scale Standard Deviation 25.9
Handling Insertion	93.4 units on a scale Standard Deviation 10.7	89.3 units on a scale Standard Deviation 13.0
Handling Removal	90.0 units on a scale Standard Deviation 13.6	92.0 units on a scale Standard Deviation 11.3

PRIMARY outcome

Timeframe: Baseline

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Comfort On Insertion	85.0 units on a scale Standard Deviation 17.0	—
Comfort After 4 Hours	91.8 units on a scale Standard Deviation 9.1	—
Comfort After 8 Hours	80.8 units on a scale Standard Deviation 15.7	—
Comfort On Removal	75.3 units on a scale Standard Deviation 19.7	—

PRIMARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=59 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Comfort Insertion	93.0 units on a scale Standard Deviation 9.6	90.6 units on a scale Standard Deviation 13.2
Comfort After 4 hours	89.7 units on a scale Standard Deviation 14.6	88.8 units on a scale Standard Deviation 11.8
Comfort After 8 hours	81.7 units on a scale Standard Deviation 17.7	79.0 units on a scale Standard Deviation 17.6
Comfort Removal	75.8 units on a scale Standard Deviation 18.8	72.4 units on a scale Standard Deviation 20.0

PRIMARY outcome

Timeframe: Baseline

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Dryness On Insertion	85.6 units on a scale Standard Deviation 26.8	—
Dryness After 4 Hours	84.0 units on a scale Standard Deviation 21.7	—
Dryness After 8 Hours	73.8 units on a scale Standard Deviation 22.0	—
Dryness On Removal	67.1 units on a scale Standard Deviation 25.3	—

PRIMARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).

Outcome measures

Measure	Overall Study Group n=33 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=26 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Dryness Insertion	94.4 units on a scale Standard Deviation 11.8	93.6 units on a scale Standard Deviation 11.6
Dryness After 4 hours	88.9 units on a scale Standard Deviation 13.3	88.0 units on a scale Standard Deviation 12.4
Dryness After 8 hours	78.5 units on a scale Standard Deviation 19.0	79.2 units on a scale Standard Deviation 16.7
Dryness Removal	72.9 units on a scale Standard Deviation 21.1	70.8 units on a scale Standard Deviation 19.1

PRIMARY outcome

Timeframe: Baseline

Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Vision Quality	92.2 units on a scale Standard Deviation 8.6	—

PRIMARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=59 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Vision Quality	89.9 units on a scale Standard Deviation 11.2	89.0 units on a scale Standard Deviation 11.7

PRIMARY outcome

Timeframe: Baseline

Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Eye Whiteness	82.5 units on a scale Standard Deviation 15.0	—

PRIMARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=59 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Eye Whiteness	85.3 units on a scale Standard Deviation 12.5	84.9 units on a scale Standard Deviation 13.5

PRIMARY outcome

Timeframe: Baseline

Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Overall Satisfaction	88.1 units on a scale Standard Deviation 14.0	—

PRIMARY outcome

Timeframe: 1 Week

Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=59 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Overall Satisfaction	85.7 units on a scale Standard Deviation 12.4	82.5 units on a scale Standard Deviation 16.1

PRIMARY outcome

Timeframe: Baseline

Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Visual Acuity logMAR MHCVA OD	-0.01 logMAR Standard Deviation 0.08	—
Visual Acuity logMAR MHCVA OS	-0.01 logMAR Standard Deviation 0.08	—
Visual Acuity logMAR BHCVA	-0.05 logMAR Standard Deviation 0.07	—

PRIMARY outcome

Timeframe: Dispense

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=59 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Visual Acuity logMAR MHCVA OD	-0.09 logMAR Standard Deviation 0.10	-0.07 logMAR Standard Deviation 0.07
Visual Acuity logMAR MHCVA OS	-0.09 logMAR Standard Deviation 0.08	-0.07 logMAR Standard Deviation 0.06
Visual Acuity logMAR BHCVA	-0.12 logMAR Standard Deviation 0.08	-0.11 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=59 Participants All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Visual Acuity logMAR	-0.06 logMAR Standard Deviation 0.06	-0.03 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.

Outcome measures

Measure	Overall Study Group n=118 Eyes All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=118 Eyes All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Wettability Right Eye	10.9 seconds Standard Deviation 6.5	9.2 seconds Standard Deviation 5.4
Wettability Left Eye	11.6 seconds Standard Deviation 9.0	9.6 seconds Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline

Population: Prior to randomization

Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.

Outcome measures

Measure	Overall Study Group n=118 Eyes All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Blood Vessel Coverage Right Eye	3.68 percentage of blood vessel coverage Standard Deviation 3.05	—
Blood Vessel Coverage Left Eye	3.74 percentage of blood vessel coverage Standard Deviation 2.74	—

SECONDARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.

Outcome measures

Measure	Overall Study Group n=59 Participants All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=118 Eyes All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Blood Vessel Coverage Right Eye	4.63 percentage of blood vessel coverage Standard Deviation 2.90	4.41 percentage of blood vessel coverage Standard Deviation 2.94
Blood Vessel Coverage Left Eye	5.00 percentage of blood vessel coverage Standard Deviation 3.32	5.25 percentage of blood vessel coverage Standard Deviation 4.42

SECONDARY outcome

Timeframe: Baseline

Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.

Outcome measures

Measure	Overall Study Group n=118 Eyes All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Conjunctival Redness Right Eye	35.1 percentage of redness Standard Deviation 1.0	—
Conjunctival Redness Left Eye	35.2 percentage of redness Standard Deviation 1.2	—

SECONDARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.

Outcome measures

Measure	Overall Study Group n=118 Eyes All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=118 Eyes All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Conjunctival Redness Right Eye	35.6 percentage of redness Standard Deviation 1.4	35.4 percentage of redness Standard Deviation 1.3
Conjunctival Redness Left Eye	35.8 percentage of redness Standard Deviation 1.4	35.4 percentage of redness Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline

Population: Prior to randomization

Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )

Outcome measures

Measure	Overall Study Group n=118 Eyes All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Corneal Staining	0.6 units on a scale Standard Deviation 0.6	—

SECONDARY outcome

Timeframe: 1 Week

Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )

Outcome measures

Measure	Overall Study Group n=118 Eyes All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=118 Eyes All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Corneal Staining	0.4 units on a scale Standard Deviation 0.4	0.5 units on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: 1 Week

Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )

Outcome measures

Measure	Overall Study Group n=118 Eyes All 59 subjects with habitual lens prior to dispense of study lenses.	Filcon II 3 n=118 Eyes All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
Conjunctival Staining	0.6 units on a scale Standard Deviation 0.5	0.6 units on a scale Standard Deviation 0.4

Adverse Events

Stenfilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Filcon II 3

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

Jonathan Walker

Opthalmic Research Group, Aston University, Birmingham, UK

Email: JWalker@coopervision.co.uk

Results disclosure agreements

• Principal investigator is a sponsor employee The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor. Assuming that the product is marketed, and only with the sponsor's permission, will they allow publication of the results of the study.
• Publication restrictions are in place

Restriction type: OTHER