Trial Outcomes & Findings for Product Performance of a Daily Disposable Contact Lens (NCT NCT01230554)

NCT ID: NCT01230554

Last Updated: 2019-08-28

Results Overview

Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 212 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2019-08-28

Participant Flow

Participant milestones

Measure	Prism I Bausch \& Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Overall Study STARTED	212
Overall Study COMPLETED	209
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Prism I Bausch \& Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Overall Study Lost to Follow-up	2
Overall Study Inability to maintain visit schedule	1

Baseline Characteristics

Product Performance of a Daily Disposable Contact Lens

Baseline characteristics by cohort

Measure	Prism I n=212 Participants Bausch \& Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Age, Continuous	25.0 years STANDARD_DEVIATION 5.2 • n=93 Participants
Sex: Female, Male Female	212 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Subjects who completed the survey.

Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor.

Outcome measures

Measure	Prism I n=210 Participants Bausch \& Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Market Research Survey Excellent	10 Participants
Market Research Survey Very Good	91 Participants
Market Research Survey Good	93 Participants
Market Research Survey Fair	16 Participants
Market Research Survey Poor	0 Participants

SECONDARY outcome

Timeframe: Over all study visits through 1 week

Population: Eligible, dispense eyes with non-missing scores.

To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor.

Outcome measures

Measure	Prism I n=424 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Lens Evaluation - Centration Excellent	287 eyes
Lens Evaluation - Centration Good	109 eyes
Lens Evaluation - Centration Fair	14 eyes
Lens Evaluation - Centration Poor	14 eyes

SECONDARY outcome

Timeframe: Over all study visits through 1 week

Population: Eligible, dispense eyes with non-missing scores.

To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with:

• Primary gaze blink
• Upgaze blink
• Upgaze lag was assessed during the slit lamp evaluation. Findings were reported as: Adequate, Excessive, Insufficient, Adherence.

Outcome measures

Measure	Prism I n=424 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Lens Evaluation - Movement Excessive	0 eyes
Lens Evaluation - Movement Insufficient	168 eyes
Lens Evaluation - Movement Adequate	246 eyes
Lens Evaluation - Movement Adherence	10 eyes

SECONDARY outcome

Timeframe: Over all study visits for 1 week

Population: Eyes with VA results

For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters).

Outcome measures

Measure	Prism I n=424 eyes Bausch \& Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch \& Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).	0.012 logMAR Standard Error 0.070

Adverse Events

Prism I

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

Robert Steffen

Bausch Health Americas, Inc

Email: Robert.Steffen@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place