Phase 3 N=204 Randomized Double-blind Treatment

Comparative Performance of PureVision Lens Designs

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT00661687 ↗

Enrolled (actual)

204

Serious AEs

0.0%

Results posted

Oct 2010

Primary outcome: Primary: Subjective Responses to Symptoms/Complaints — 80.0; 81.2 Visual Analogue Scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Currently Marketed PureVision Contact Lens. (Device); Alternate Design of the PureVision Contact Lens. (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch & Lomb Incorporated
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Subjective Responses to Symptoms/Complaints	80.0; 81.2	—
SECONDARY LogMAR Visual Acuity	0.001; 0.003	—
SECONDARY Lens Characteristics	75; 78; 182; 182; 181; 179	—

Summary

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Eligibility Criteria

Inclusion Criteria

subject is myopic
VA correctable to 0.3 logMAR or better (driving vision)
Clear central cornea

Exclusion Criteria

Systemic disease affecting ocular health
using systemic or topical medications
wear monovision, multifocal or toric contact lenses
Any grade 2 or greater slit lamp findings

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00661687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.