Comparative Performance of PureVision Lens Designs

Phase 3

Completed

• Conditions: Myopia
• Interventions: Device: Currently Marketed PureVision Contact Lens.; Device: Alternate Design of the PureVision Contact Lens.

• Registration Number: NCT00661687
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-02
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-18
• Study Completion: 2008-06
• Results First Submitted: 2009-02-20
• Results First Submitted QC: 2010-09-27
• Results First Posted: 2010-10-15
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Purevision Contact Lens #1	Currently Marketed PureVision Contact Lens.	PureVision Soft Contact Lens Design (currently marketed)
PureVision Contact Lens #2	Alternate Design of the PureVision Contact Lens.	Redesign of the currently marketed PureVision soft contact lens.

Primary Outcome Measures

Name	Time	Method
Subjective Responses to Symptoms/Complaints	Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits	Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
LogMAR Visual Acuity	Mean over all visits - 1 day, 1 week, 1 month	The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.
Lens Characteristics	Over all scheduled visits day 1 - 1 month	Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.

Trial Locations

Locations (2)

Laser Focus Sdn Bhd, Vision Correction Centre; 🇲🇾 Johor Bahru, Malaysia

Asian Eye Institute; 🇵🇭 Makati City, Philippines