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OpenTrials
Completed

NCT Number: NCT01518868

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

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.

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Key information

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.
  • 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.

Treatment and study plan

Investigational Contact Lens

Device

Worn on a daily wear basis for one week.

PureVision Contact Lens

Device

Worn on a daily wear basis for one week

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 26, 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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