Trial Outcomes & Findings for A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use (NCT NCT00784641)

Results Overview

The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

567 participants

Primary outcome timeframe

At dispensing

Results posted on

2020-10-06

Participant Flow

There were 567 participants enrolled (1134 eyes).

Participant milestones

Participant milestones
Measure	Novel Bausch & Lomb Contact Lens Novel Bausch \& Lomb daily disposable contact lenses Novel Bausch \& Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks.	SofLens Bausch \& Lomb SofLens daily disposable contact lenses Bausch \& Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks.	Acuvue Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks.
Overall Study STARTED	189	189	189
Overall Study COMPLETED	183	186	187
Overall Study NOT COMPLETED	6	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Novel Bausch & Lomb Contact Lens n=188 Participants Novel Bausch \& Lomb daily disposable contact lenses Novel Bausch \& Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks.	SofLens n=186 Participants Bausch \& Lomb SofLens daily disposable contact lenses Bausch \& Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks.	Acuvue n=187 Participants Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks.	Total n=561 Participants Total of all reporting groups
Age, Continuous	32.8 years n=5 Participants	32.5 years n=7 Participants	32.5 years n=5 Participants	32.6 years n=4 Participants
Sex: Female, Male Female	147 Participants n=5 Participants	136 Participants n=7 Participants	137 Participants n=5 Participants	420 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	50 Participants n=7 Participants	50 Participants n=5 Participants	141 Participants n=4 Participants

PRIMARY outcome

Timeframe: At dispensing

Population: Eyes that were dispensed contact lenses are included in the analysis population.

The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.

Outcome measures

Outcome measures
Measure	Novel Bausch & Lomb Contact Lens n=376 eyes Novel Bausch \& Lomb daily disposable contact lenses Novel Bausch \& Lomb daily disposable contact lenses: Lenses to be worn and replaced daily for 2 weeks.	SofLens n=372 eyes Bausch \& Lomb SofLens daily disposable contact lenses Bausch \& Lomb SofLens daily disposable contact lenses.: Lenses to be worn and replaced daily for 2 weeks.	Acuvue n=374 eyes Johnson and Johnson 1-Day Acuvue Moist contact lenses Johnson and Johnson 1-Day Acuvue Moist contact lenses: Lenses to be worn and replaced daily for 2 weeks.
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey Lens handling upon insertion	340 eyes	293 eyes	326 eyes
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey Burning/stinging upon insertion	363 eyes	333 eyes	339 eyes
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey Comfort	333 eyes	289 eyes	354 eyes
Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey Vision	324 eyes	338 eyes	363 eyes

Adverse Events

Novel Bausch & Lomb Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SofLens

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 Health

Phone: 908-300-9920

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