Trial Outcomes & Findings for Performance Assessment of a Modified Daily Disposable Contact Lens (NCT NCT03762668)

Last Updated: 2020-01-13

Results Overview

Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA.

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

Day 1 Dispense, Day 7 Follow-Up

Results posted on

2020-01-13

Participant Flow

This study was conducted at 5 investigative sites located in the United States.

Of the 62 subjects enrolled, 2 were exited as screen failures prior to randomization. This reporting group includes all randomized and exposed subjects (60).

Participant milestones

Participant milestones
Measure	MDACL, Then DACL Modified delefilcon A contact lenses (MADCL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.	DACL, Then MDACL DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
Period 1, First Week of Wear STARTED	30	30
Period 1, First Week of Wear COMPLETED	30	29
Period 1, First Week of Wear NOT COMPLETED	0	1
Period 2, Second Week of Wear STARTED	30	29
Period 2, Second Week of Wear COMPLETED	30	29
Period 2, Second Week of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	MDACL, Then DACL Modified delefilcon A contact lenses (MADCL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality.	DACL, Then MDACL DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
Period 1, First Week of Wear Withdrawal by Subject	0	1

Baseline Characteristics

Performance Assessment of a Modified Daily Disposable Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MDACL, Then DACL n=30 Participants MDACL worn first, followed by DACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.	DACL, Then MDACL n=30 Participants DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.	Total n=60 Participants Total of all reporting groups
Age, Continuous	32.7 years STANDARD_DEVIATION 9.3 • n=5 Participants	30.7 years STANDARD_DEVIATION 8.6 • n=7 Participants	31.7 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 Dispense, Day 7 Follow-Up

Population: All randomized subjects who were exposed to any study lenses evaluated in the study (Full Analysis Set), with non missing data.

Outcome measures

Outcome measures
Measure	MDACL n=118 eyes MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized	DACL n=120 eyes DACL worn for approximately 1 week, Period 1 or Period 2, as randomized
High Contrast Distance Visual Acuity (logMAR) Day 1 Dispense	-0.04 logMar Standard Deviation 0.07	-0.04 logMar Standard Deviation 0.07
High Contrast Distance Visual Acuity (logMAR) Day 7 Follow-Up	-0.05 logMar Standard Deviation 0.07	-0.05 logMar Standard Deviation 0.07

Adverse Events

MDACL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DACL

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

Sr. CDMA Project Lead, Vision Care

Alcon Research, LLC

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