Trial Outcomes & Findings for Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens (NCT NCT01386008)

Results Overview

Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Results posted on

2019-09-04

Participant Flow

28 recruited, 4 disqualified due to significant anterior ocular health findings, 4 passed screening and scheduled for lense fit/dispense when study discontinued.

Participant milestones

Participant milestones
Measure	Overall Study Group Participants wear one enfilcon A (test) contact lens in one eye and one senofilcon A (comparator) contact lens in the other. Both lenses are worn daily wear.
Overall Study STARTED	20
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Study Group Participants wear one enfilcon A (test) contact lens in one eye and one senofilcon A (comparator) contact lens in the other. Both lenses are worn daily wear.
Overall Study exited w/o incident /study discontinued	17
Overall Study Adverse Event	3

Baseline Characteristics

Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Group n=20 Participants Participants wear one enfilcon A (test) contact lens in one eye and one senofilcon A (comparator) contact lens in the other. Both lenses are worn daily wear.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	23 Years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Population: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.

Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.

Outcome measures

Outcome measures
Measure	Enfilcon A + Senofilcon A n=20 Participants Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Subjective Comfort Preference - Participants Preference Response Preferred Test lens Visit 1	7 participants
Subjective Comfort Preference - Participants Preference Response No Preference Visit 1	8 participants
Subjective Comfort Preference - Participants Preference Response Preferred Control Lens Visit 1	5 participants
Subjective Comfort Preference - Participants Preference Response Preferred Test lens Visit 2	0 participants
Subjective Comfort Preference - Participants Preference Response No Preference Visit 2	1 participants
Subjective Comfort Preference - Participants Preference Response Preferred Control lens Visit 2	0 participants

PRIMARY outcome

Timeframe: Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Population: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. Change from baseline V1 over 30 days V4 cannot be analyzed.

Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Population: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.

Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)

Outcome measures

Outcome measures
Measure	Enfilcon A + Senofilcon A n=20 Participants Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Investigator Surface Preference Preferred Test Lens V1	6 participants
Investigator Surface Preference No Preference V1	5 participants
Investigator Surface Preference Preferred Control Lens V1	9 participants
Investigator Surface Preference Preferred Test Lens V2	0 participants
Investigator Surface Preference No Preference V2	1 participants
Investigator Surface Preference Preferred Control Lens V2	0 participants

SECONDARY outcome

Timeframe: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Population: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.

Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)

Outcome measures

Outcome measures
Measure	Enfilcon A + Senofilcon A n=20 Participants Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Investigator Fit Preference Preferred Test Lens V1	7 participants
Investigator Fit Preference No Preference V1	10 participants
Investigator Fit Preference Preferred Control Lens V1	3 participants
Investigator Fit Preference Preferred Test Lens V2	1 participants
Investigator Fit Preference No Preference V2	0 participants
Investigator Fit Preference Preferred Control Lens V2	0 participants

Adverse Events

Overall Study Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Overall Study Group n=20 participants at risk investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
Eye disorders blurred vision	15.0% 3/20 • Number of events 3

Additional Information

Meng Lin, OD, PhD

Clinical Research Center (CRC) UC Berkeley School of Optometry

Phone: (510) 642-9731

Results disclosure agreements

Principal investigator is a sponsor employee The principal investigators are not permitted to publish or make public any of the results without prior written approval from the Sponsor.
Publication restrictions are in place

Restriction type: OTHER