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Product Performance of a Daily Disposable Contact Lens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230554
Recruitment Status : Completed
First Posted : October 29, 2010
Results First Posted : August 14, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myopia Device: Daily disposable cosmetic tint lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 212 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study to Assess the Product Performance of a Daily Disposable Contact Lens
Study Start Date : August 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics Eye Wear

Arm Intervention/treatment
Experimental: Prism I
Bausch & Lomb daily disposable cosmetic tint contact lens
Device: Daily disposable cosmetic tint lens
Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   15 Years to 38 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230554


Locations
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Singapore
Bausch & Lomb
Singapore, Singapore, 556741
Sponsors and Collaborators
Bausch & Lomb Incorporated
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01230554    
Other Study ID Numbers: 654
First Posted: October 29, 2010    Key Record Dates
Results First Posted: August 14, 2019
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Bausch & Lomb Incorporated:
contact lens
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases