A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

September 9, 2020 updated by: Bausch & Lomb Incorporated
The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
  • Have no active ocular disease or allergic conjunctivitis.
  • Must not be using any topical ocular medications.
  • Must habitually use a lens care product for lens cleaning, disinfecting, and storage.

Exclusion Criteria:

  • Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Anisometropia (spherical equivalent) of greater than 2.00 D.
  • 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 study products.
  • Ocular astigmatism of greater than 1.00 D in either eye.
  • Have had any corneal surgery (ie, refractive surgery).
  • Uses AMO Ultra Care as their habitual lens care regimen.
  • Is a toric contact lens wearer.
  • Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
  • An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigational contact lens
multifocal high add soft contact lens
Device: Investigational contact lens
Worn on a daily wear basis for one week.
Active Comparator: PureVision contact lens
Multi-focal contact lens
Device: PureVision contact lens
Worn on a daily wear basis for one week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity
Time Frame: At 2 weeks follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
At 2 weeks follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms/Complaints
Time Frame: At 2 weeks follow up
Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
At 2 weeks follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 26, 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

Other Study ID Numbers

  • 743E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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