Trial Outcomes & Findings for Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens (NCT NCT04055519)

Last Updated: 2021-05-13

Results Overview

Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

Day 30 after a minimum of 6 hours of wear, each product

Results posted on

2021-05-13

Participant Flow

Subjects were enrolled at 3 investigative sites located in the US.

This reporting group includes all randomized subjects/eyes (36/72) as treated. Note: Two subjects received investigational product misallocations and were exposed to the incorrect study product in the sequence.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	LID017569, Then Biofinity Lehfilcon A contact lenses worn in Period 1, with comfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.	Biofinity, Then LID017569 Comfilcon A contact lenses worn in Period 1, with lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
First Wear Period (30 Days) STARTED	16 32	20 40
First Wear Period (30 Days) COMPLETED	16 32	20 40
First Wear Period (30 Days) NOT COMPLETED	0 0	0 0
Second Wear Period (30 Days) STARTED	16 32	20 40
Second Wear Period (30 Days) COMPLETED	16 32	20 40
Second Wear Period (30 Days) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=36 Participants LID017569 and Biofinity contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. Each product was worn in both eyes on a daily wear basis at least 8 hours a day, 5 days a week, for 30 days. Lenses were removed nightly for cleaning and disinfection.
Age, Continuous	34.1 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30 after a minimum of 6 hours of wear, each product

Population: This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study.