A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Spectacles; Device: PureVision2 HD contact lenses

• Registration Number: NCT01416142
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-08
• Study First Submitted: 2011-08-11
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Study Completion: 2011-09
• Results First Submitted: 2013-02-13
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-07
• Last Update Submitted: 2013-11-07
• Results First Posted: 2013-12-25
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

• Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
• Subjects must be myopic or hyperopic and require lens correction in each eye
• Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.

Exclusion Criteria

• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• Allergic to any component in the Biotrue multi-purpose solution

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spectacles	Spectacles	The subject's habitual spectacles (updated or confirmed as correct within the last 2 years)
PureVision2 HD contact lenses	PureVision2 HD contact lenses	Currently marketed Bausch + Lomb PureVision2 HD contact lenses

Primary Outcome Measures

Name	Time	Method
Visual Acuity	Screening visit (Visit 1) and one week follow-up(Visit 3)	Visual acuity(VA) measured at the screening visit (all eligible participants) while wearing spectacles and the VA measured at the end of study (Visit 3) 1-Week wearing PureVision2 HD lenses. VA wearing spectacles vs. VA wearing PureVision2 HD Lenses, lower the number the better the VA.

Secondary Outcome Measures

Name	Time	Method
Preference for Test Lens	During the movie (Visit 2)	Proportion of participants preferring the Test lens over their spectacles. Participants changed from Spectacles to PureVision Lenses or PureVision Lenses to spectacles during movie intermission.

Trial Locations

Locations (1)

Bausch & Lomb, Inc.; 🇺🇸 Rochester, New York, United States