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OpenTrials
Completed

NCT Number: NCT01449526

A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design

The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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 myopic, and wear contact lenses in each eye.
  • Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.

Exclusion criteria

  • Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects with an active ocular disease or who are using any ocular medication.
  • Subjects with any grade 2 or greater finding during the slit lamp examination.
  • Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects who are allergic to any component in the study care products.

Treatment and study plan

B&L Investigational Contact Lens

Device

Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

B&L PureVision Contact Lens

Device

Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.

Primary outcomes

  1. Visual Acuity (VA)

    Time frame: 4 visits over 3 months

    Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. This measure is an average from 4 visits taking place over 3 months.

Secondary outcomes

  1. Slit Lamp > Grade 2

    Time frame: 3 months

    Proportion of eyes with any slit lamp findings greater than grade 2 at any visit between the Test and Control lenses.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 10, 2011
Registry last updated
Feb 18, 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.

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