CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
B+L Biotrue MPS and B+L PureVisiondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01268306
NCT01268306Phase 4Completed

A Single-site, Open-Label Prospective Evaluation of Biocompatibility and Corneal Staining Associated With Use of Bausch & Lomb (B+L) BioTrue Contact Lens Multi-purpose Solution (MPS) and B+L PureVision Contact Lenses.

Epstein, Arthur B., OD, FAAO·interventional·Posted Dec 30, 2010·Updated Aug 22, 2016

In Brief

A Phase 4 clinical trial evaluating B+L Biotrue MPS and B+L PureVision for Keratitis. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Corneal epithelial disruption, commonly termed "corneal staining" has been frequently associated with contact lens wear. Previous research has demonstrated higher levels of observed corneal staining when certain combinations of contact lenses and lens care products are used, particularly under daily wear regimens. B+L lenses made from Balafilcon (PureVision) have been associated with the highest rates of observed staining. Additionally, polyhexamethylene biguanide (PHMB) based lens care products, specifically B+L ReNu MultiPlus have been implicated in higher rates of staining. In general, many lenses constructed from newer, silicone hydrogel (SiHy) materials appear more susceptible to increased rates and amounts of corneal staining. Although the clinical significance of staining is debated, most clinicians agree that less staining is preferable to greater amounts of staining. Advances in understanding as well as the specifics of lens care product formulation ideally will have resulted in design of newer products that minimize corneal staining and maximize product performance. This study will examine rates of corneal staining using B+L's recently introduced lens care product: BioTrue with the B+L PureVision lens which has previously been associated with the highest levels of staining.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratitis
CountriesUnited States
CollaboratorsAlcon Research

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2010
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.5 years ago

Interventions

B+L Biotrue MPS and B+L PureVisiondevice

Subjects use Bausch \& Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses