Trial Outcomes & Findings for A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens (NCT NCT01192126)

Results Overview

Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

Dispensing Visit and 1 week follow-up

Results posted on

2014-01-03

Participant Flow

This was a two week, multicenter, open label, bilateral, crossover study. First Participant was enrolled 08/23/2010 and last participant exited the study 10/08/2010.

102 participants(204 eyes) were enrolled in this study.

Participant milestones

Participant milestones
Measure	B & L Daily Disposable Lens, Then J & J Acuvue Moist Bausch \& Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson \& Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.	J & J Acuvue Moist, Then B & L Daily Disposable Lens Johnson \& Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch \& Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
First Intervention (1 Week) STARTED	51	51
First Intervention (1 Week) COMPLETED	49	50
First Intervention (1 Week) NOT COMPLETED	2	1
Second Intervention (1 Week) STARTED	49	50
Second Intervention (1 Week) COMPLETED	49	50
Second Intervention (1 Week) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	B & L Daily Disposable Lens, Then J & J Acuvue Moist Bausch \& Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson \& Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.	J & J Acuvue Moist, Then B & L Daily Disposable Lens Johnson \& Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch \& Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
First Intervention (1 Week) Unacceptable Distance Visual Acuity	1	0
First Intervention (1 Week) Lost to Follow-up	1	1

Baseline Characteristics

A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=102 Participants All eligible subjects
Age Continuous	28.0 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants

PRIMARY outcome

Timeframe: Dispensing Visit and 1 week follow-up

Population: All Eligible Dispensed Eyes

Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.

Outcome measures

Outcome measures
Measure	Bausch & Lomb New Daily Disposable n=198 eyes New daily disposable contact lenses Bausch \& Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.	Johnson & Johnson Acuvue Moist n=198 eyes Contact lenses Johnson \& Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
Visual Acuity Dispensing Visit	-0.056 LogMAR Standard Deviation 0.079	-0.070 LogMAR Standard Deviation 0.066
Visual Acuity 1 Week Follow-up	-0.063 LogMAR Standard Deviation 0.079	-0.065 LogMAR Standard Deviation 0.079

PRIMARY outcome

Timeframe: All study visits from screening through 2 week follow-up

Population: All Dispensed Eyes

Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp \> 2.

Outcome measures

Outcome measures
Measure	Bausch & Lomb New Daily Disposable n=198 eyes New daily disposable contact lenses Bausch \& Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.	Johnson & Johnson Acuvue Moist n=198 eyes Contact lenses Johnson \& Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
Slit Lamp Examination > Grade 2	0 Eyes	0 Eyes

Adverse Events

Bausch & Lomb New Daily Disposable

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Johnson & Johnson Acuvue Moist

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

Dr. Robert Steffen OD

Bausch & Lomb Incorporated

Phone: 585-338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER