Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

Not Applicable

Completed

• Conditions: Vision Disorders
• Interventions: Device: SofLens59 contact lens; Device: PureVision Multi-Focal contact lenses

• Registration Number: NCT00985231
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

This study is being conducted to evaluate Bausch \& Lomb PureVision Multi-Focal contact lenses compared to the Bausch \& Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Results First Submitted: 2011-02-17
• Results First Submitted QC: 2011-02-17
• Results First Posted: 2011-03-14
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
• Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion Criteria

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
• Subjects with any systemic disease affecting ocular health
• Subjects with an active ocular disease or using any ocular medication.
• Subjects who have had any corneal surgery (eg, refractive surgery).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SofLens59 contact lens	SofLens59 contact lens	-
PureVision Multi-Focal contact lenses	PureVision Multi-Focal contact lenses	-

Primary Outcome Measures

Name	Time	Method
Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.	2 weeks	Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.

Secondary Outcome Measures

Name	Time	Method
Subjective Ratings of Eye Strain	2 week visit	Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always

Trial Locations

Locations (1)

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