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OpenTrials
Completed

NCT Number: NCT01230554

Product Performance of a Daily Disposable Contact Lens

The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

15 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb

Singapore, 556741

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.

Exclusion criteria

  • Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
  • Subjects who have 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 with an active ocular disease or are using any ocular medication.
  • Subjects with any scar or neovascularization within the central 4 mm of the cornea.
  • Subjects who are aphakic or amblyopic.
  • Subjects who have had any corneal surgery (eg, refractive surgery).
  • Subjects who currently wear monovision, multifocal, or toric contact lenses.

Treatment and study plan

Daily disposable cosmetic tint lens

Device

Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.

Primary outcomes

  1. Market Research Survey

    Time frame: 1 week

    Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor.

Secondary outcomes

  1. Lens Evaluation - Centration

    Time frame: Over all study visits through 1 week

    To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor.

  2. Lens Evaluation - Movement

    Time frame: Over all study visits through 1 week

    To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with:

    • Primary gaze blink
    • Upgaze blink
    • Upgaze lag was assessed during the slit lamp evaluation. Findings were reported as: Adequate, Excessive, Insufficient, Adherence.

  3. Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).

    Time frame: Over all study visits for 1 week

    For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters).

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Study to Assess the Product Performance of a Daily Disposable Contact Lens

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2010
Registry last updated
Aug 28, 2019

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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