Trial Outcomes & Findings for Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear (NCT NCT03095027)

Results Overview

VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

Baseline/Dispense (Day 1), Week 1, each product

Results posted on

2019-02-04

Participant Flow

Subjects were recruited from 3 study centers located in the United States.

Of the 54 enrolled, 3 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (51).

Participant milestones

Participant milestones
Measure	FID122819, Then Stenfilcon A FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week.	Stenfilcon A, Then FID122819 Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week.
Period 1, First Week of Wear STARTED	27	24
Period 1, First Week of Wear COMPLETED	27	24
Period 1, First Week of Wear NOT COMPLETED	0	0
Period 2, Second Week of Wear STARTED	27	24
Period 2, Second Week of Wear COMPLETED	26	24
Period 2, Second Week of Wear NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	FID122819, Then Stenfilcon A FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week.	Stenfilcon A, Then FID122819 Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week.
Period 2, Second Week of Wear Adverse Event	1	0

Baseline Characteristics

Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=51 Participants FID122819 and stenfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Age, Continuous	32.5 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline/Dispense (Day 1), Week 1, each product

Population: Full Analysis Set

VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.

Outcome measures

Outcome measures
Measure	FID112819 n=102 Eyes FID122819 contact lenses worn during Period 1 or Period 2 for 1 week	Stenfilcon A n=102 Eyes Stenfilcon A contact lenses worn during Period 1 or Period 2 for 1 week
Visual Acuity (VA) Dispense	-0.08 logMAR Standard Deviation 0.06	-0.09 logMAR Standard Deviation 0.06
Visual Acuity (VA) Week 1	-0.09 logMAR Standard Deviation 0.06	-0.09 logMAR Standard Deviation 0.06

Adverse Events

FID122819

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stenfilcon 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

Senior Clinical Project Lead, GCRA - Vision Care

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER