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

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

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: LD118033 contact lens; Device: PureVision multifocal contact lens

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LD118033 contact lens; Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis.	Device: LD118033 contact lens; Multifocal contact lens worn on a daily wear basis for 1 week
Active Comparator: PureVision multifocal contact lens; PureVision multifocal low add soft contact lens, to be worn on a daily wear basis.	Device: PureVision multifocal contact lens; PureVision multifocal contact lens worn on a daily wear basis for 1 week.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Gerard Cairns, PhD, MCOptom, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 27, 2012

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: 744E