Trial Outcomes & Findings for Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses (NCT NCT01268306)

Results Overview

The number of participants who have disturbance of their corneal epithelium visualized by using applied sodium fluorescein solution (as a disclosing agent) evaluated by slit lamp biomicroscopy. Clinically significant staining is described as sufficiently diffuse and deep to pose potential risk of infection by the examiners assessment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

2-4 hours after contact lens insertion

Results posted on

2016-08-22

Participant Flow

Subjects randomly recruited from contact lens wearing population in an optometric practice

Patients with spherical contact lens corrections who achieved acceptable acuity with test lenses were offered study participation.

Participant milestones

Participant milestones
Measure	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch \& Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch \& Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Overall Study Lost to Follow-up	1

Baseline Characteristics

Study of the Presence and Extent of Corneal Disturbance Associated With B+L Biotrue MPS Used With B+L PureVision Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses n=8 Participants Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch \& Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-4 hours after contact lens insertion

Population: Subjects who returned for examination post-challenge in the allotted time and who had observable corneal staining on slit lamp examination

The number of participants who have disturbance of their corneal epithelium visualized by using applied sodium fluorescein solution (as a disclosing agent) evaluated by slit lamp biomicroscopy. Clinically significant staining is described as sufficiently diffuse and deep to pose potential risk of infection by the examiners assessment.

Outcome measures

Outcome measures
Measure	Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses n=7 Participants Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch \& Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
Number of Participants Wiith Corneal Staining Clinically signficant staining	1 participants
Number of Participants Wiith Corneal Staining Clinically insigificant staining	6 participants

Adverse Events

Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses

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. Arthur Epstein

Arthur B. Epstein, OD

Phone: 424-226-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place