Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens (NCT NCT04158466)

Last Updated: 2020-11-19

Results Overview

Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits.

Recruitment status

COMPLETED

Study phase

Target enrollment

252 participants

Primary outcome timeframe

3 months

Results posted on

2020-11-19

Participant Flow

There were 252 participants randomized but 251 participants received treatment. Participants are summarized by actual treatment group received.

Participant milestones

Participant milestones
Measure	Kalifilcon A Daily Disposable Contact Lenses Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens	Biotrue ONEday Daily Disposable Contact Lenses Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens
Overall Study STARTED	124	127
Overall Study COMPLETED	121	126
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of Kalifilcon A Daily Disposable Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Kalifilcon A Daily Disposable Contact Lenses n=124 Participants Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens	Biotrue ONEday Daily Disposable Contact Lenses n=127 Participants Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens	Total n=251 Participants Total of all reporting groups
Age, Continuous	35.9 years n=5 Participants	33.6 years n=7 Participants	34.7 years n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	94 Participants n=7 Participants	182 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	33 Participants n=7 Participants	69 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	60 Participants n=5 Participants	55 Participants n=7 Participants	115 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	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	64 Participants n=7 Participants	123 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
Average Daily Wear Time	13.5 hours per day n=5 Participants	13.4 hours per day n=7 Participants	13.4 hours per day n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The per protocol population consisted of randomized without important (major) protocol deviations. It is a subset of the participants randomized and treated.

Outcome measures

Outcome measures
Measure	Kalifilcon A Daily Disposable Contact Lenses n=120 Participants Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens	Biotrue ONEday Daily Disposable Contact Lenses n=254 eyes Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens
Mean logMAR Contact Lens Visual Acuity	-0.066 units on a scale Standard Error 0.0034	-0.060 units on a scale Standard Error 0.0032

PRIMARY outcome

Timeframe: 3 months

During an examination of both eyes without lenses, graded slit lamp findings will be assessed for each eye using Grades 0 (none), 1 (trace), 2 (mild), 3 (moderate), and 4 (severe). Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than Grade 2 at any visit (Absent or Present). Epithelial edema, epithelial microcysts, corneal staining, limbal Injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be evaluated.

Outcome measures

Outcome measures
Measure	Kalifilcon A Daily Disposable Contact Lenses n=248 eyes Participants will wear Bausch + Lomb kalifilcon A daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Kalifilcon A Daily Disposable Contact Lenses: Contact lens	Biotrue ONEday Daily Disposable Contact Lenses n=254 eyes Participants will wear Bausch + Lomb Biotrue ONEday daily disposable contact lenses for at least 8 hours per day at least 5 days per week for approximately 3 months. Participants will be provided with Bausch + Lomb Sensitive Eyes Drops for use as needed during the study and lens cases for return of worn study lenses to the Investigator at the end of the study. Biotrue ONEday Daily Disposable Contact Lenses: Contact lens
Proportion of Participants With Slit Lamp Findings Greater Than Grade 2	0 eyes	0 eyes

Adverse Events

Kalifilcon A Daily Disposable Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biotrue ONEday Daily Disposable Contact Lenses

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

Study Director

Bausch Health

Phone: (585) 338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER