Trial Outcomes & Findings for Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens (NCT NCT03586167)

Last Updated: 2021-06-30

Results Overview

VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.

Recruitment status

COMPLETED

Study phase

Target enrollment

88 participants

Primary outcome timeframe

Day 30

Results posted on

2021-06-30

Participant Flow

Subjects were recruited from 4 study centers located in the US.

Of the 88 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (86).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID014341 LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis	Biofinity Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
Overall Study STARTED	58 116	28 56
Overall Study COMPLETED	57 114	28 56
Overall Study NOT COMPLETED	1 2	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	LID014341 LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis	Biofinity Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
Overall Study Other	1	0

Baseline Characteristics

Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LID014341 n=116 Eyes LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis	Biofinity n=56 Eyes Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis	Total n=172 Eyes Total of all reporting groups
Age, Continuous	39.0 years STANDARD_DEVIATION 11.6 • n=5 Participants	40.7 years STANDARD_DEVIATION 12.9 • n=7 Participants	39.6 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	20 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	8 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	56 Participants n=5 Participants	26 Participants n=7 Participants	82 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	2 Participants n=5 Participants	0 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	25 Participants n=7 Participants	77 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

PRIMARY outcome

Timeframe: Day 30

Population: Safety Analysis Set. Overall number of units analyzed is the number of eyes with non-missing response.

Outcome measures

Outcome measures
Measure	LID014341 n=114 Eyes LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis	Biofinity n=56 Eyes Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis
Distance Visual Acuity (VA)	-0.09 logMAR Standard Deviation 0.07	-0.09 logMAR Standard Deviation 0.07

Adverse Events

LID014341

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biofinity

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

CDMA Project Lead

Alcon Research

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