Trial Outcomes & Findings for Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism (NCT NCT03681808)

NCT ID: NCT03681808

Last Updated: 2021-01-08

Results Overview

The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 242 participants
• Primary outcome timeframe: Evaluated at the 1 week follow up visit
• Results posted on: 2021-01-08

Participant Flow

Participant milestones

Measure	Biotrue Biotrue ONEday for Astigmatism Soft Contact Lens®	Acuvue 1-Day Acuvue Moist for Astigmatism Contact Lens
Overall Study STARTED	123	119
Overall Study COMPLETED	109	102
Overall Study NOT COMPLETED	14	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism

Baseline characteristics by cohort

Measure	Biotrue n=123 Participants Biotrue ONEday for Astigmatism Soft Contact Lens®	Acuvue n=119 Participants 1-Day Acuvue Moist for Astigmatism Contact Lens	Total n=242 Participants Total of all reporting groups
Age, Continuous	33.7 years n=5 Participants	32.9 years n=7 Participants	33.3 years n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	72 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	60 Participants n=5 Participants	59 Participants n=7 Participants	119 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	49 Participants n=7 Participants	91 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ancestry Chinese	45 Participants n=5 Participants	41 Participants n=7 Participants	86 Participants n=5 Participants
Ancestry Non-Chinese	78 Participants n=5 Participants	78 Participants n=7 Participants	156 Participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluated at the 1 week follow up visit

Population: The Per Protocol (PP) Population included all randomized participants without major protocol deviations who completed the study.

The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes

Outcome measures

Measure	Biotrue n=106 Participants Biotrue ONEday for Astigmatism Soft Contact Lens®	Acuvue n=98 Participants 1-Day Acuvue Moist for Astigmatism Contact Lens
Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better	105 Participants	92 Participants

Adverse Events

Biotrue

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acuvue

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 & Lomb

Phone: 585-338-6399

Email: Robert.Steffen@bausch.com

Results disclosure agreements

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

Restriction type: OTHER