Skip to main content
OpenTrials
Completed

NCT Number: NCT00985231

Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vision Disorders Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

30 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb

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

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
  • Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion criteria

  • Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
  • Subjects with any systemic disease affecting ocular health
  • Subjects with an active ocular disease or using any ocular medication.
  • Subjects who have had any corneal surgery (eg, refractive surgery).

Treatment and study plan

PureVision Multi-Focal contact lenses

Device

Contact lenses to be worn on a daily wear basis for 2 weeks.

SofLens59 contact lens

Device

Contact lenses to be worn on a daily wear basis for 2 weeks.

Primary outcomes

  1. Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.

    Time frame: 2 weeks

    Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.

Secondary outcomes

  1. Subjective Ratings of Eye Strain

    Time frame: 2 week visit

    Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 28, 2009
Registry last updated
Mar 24, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.