A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: PureVision multifocal contact lens; Device: LD118033 contact lens

• Registration Number: NCT01539694
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this study is to evaluate the product performance of an investigational multifocal low add soft contact lens.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-02
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-22
• Study First Posted: 2012-02-27
• Study Completion: 2012-03
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Results First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Have physiologically normal anterior segments.
• Be adapted wearers of soft contact lenses and wear a lens in each eye.
• Be presbyopic and require near add correction in each eye.
• Have no active ocular disease or allergic conjunctivitis.
• Must not be using any topical ocular medications.

Exclusion Criteria

• Any Grade 2 or greater finding during the slit lamp examination.
• Any scar or neovascularization within the central 4mm of the cornea.
• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Allergic to any component in the study products.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• An active ocular disease, any corneal infiltrative response or are using any ocular medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PureVision multifocal contact lens	PureVision multifocal contact lens	PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.
LD118033 contact lens	LD118033 contact lens	Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.

Primary Outcome Measures

Name	Time	Method
Visual Acuity	At 1 week follow up	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Secondary Outcome Measures

Name	Time	Method
Symptoms/Complaints	At 1 week follow up	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

Trial Locations

Locations (1)

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