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OpenTrials
Completed

NCT Number: NCT01539694

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LD118033 contact lens

Device

Multifocal contact lens worn on a daily wear basis for 1 week

PureVision multifocal contact lens

Device

PureVision multifocal contact lens worn on a daily wear basis for 1 week.

Primary outcomes

  1. Visual Acuity

    Time frame: At 1 week follow up

    Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Secondary outcomes

  1. Symptoms/Complaints

    Time frame: At 1 week follow up

    Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 27, 2012
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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