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OpenTrials
Completed

NCT Number: NCT00784641

A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use

Evaluation of the clinical performance of a novel Bausch & Lomb daily disposable contact lens when compared to the currently marketed Bausch & Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. James Ferrari

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be myopic and require lens correction in both eyes.

Exclusion criteria

  • Subjects with any systemic disease affecting ocular health.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects wearing monovision, multifocal or toric contact lenses.
  • Subjects with grade 2 or greater slit lamp findings.

Treatment and study plan

Novel Bausch & Lomb daily disposable contact lenses

Device

Lenses to be worn and replaced daily for 2 weeks.

Bausch & Lomb SofLens daily disposable contact lenses.

Device

Lenses to be worn and replaced daily for 2 weeks.

Johnson and Johnson 1-Day Acuvue Moist contact lenses

Device

Lenses to be worn and replaced daily for 2 weeks.

Primary outcomes

  1. Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey

    Time frame: At dispensing

    The initial lens performance survey was administered at the Screening/Dispensing Visit. Scores were captured on a scale from 0 to 100, with 100 being the most favorable score. Favorable responses were defined as scores of 80 or greater.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Nov 4, 2008
Registry last updated
Oct 6, 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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