Trial Outcomes & Findings for One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens (NCT NCT00902850)

Results Overview

Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Insertion, 4 hours & End of Day

Results posted on

2015-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	SofLens Daily Disposable SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours	Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours
Overall Study STARTED	14	14
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SofLens Daily Disposable SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours	Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours
Overall Study Physician Decision	2	2

Baseline Characteristics

One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SofLens Daily Disposable n=14 Participants SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours	Marketed 1 Day Contact Lens n=14 Participants Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours	Total n=28 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	40 years n=7 Participants	40 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Insertion, 4 hours & End of Day

Population: All eligible participants

Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.

Outcome measures

Outcome measures
Measure	SofLens Daily Disposable n=12 Participants SofLens Daily Disposable Lenses SofLens Daily Disposable: Lenses to be worn for 8-16 hours	Marketed 1 Day Contact Lens n=12 Participants Marketed 1 Day Contact Lens Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours
Clinical Performance Lens Insertion	98.1 units on a scale	100 units on a scale
Clinical Performance 4 Hours after insertion	97.5 units on a scale	98.1 units on a scale
Clinical Performance End of Day (8-16 hours)	91.9 units on a scale	91.7 units on a scale

Adverse Events

SofLens Daily Disposable

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Marketed 1 Day Contact Lens

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, OD, MS

Bausch & Lomb Incorporated

Phone: 585-338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place