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
|Condition or disease||Intervention/treatment||Phase|
|Myopia||Device: Daily disposable cosmetic tint lens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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).
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
|Bausch & Lomb|
|Singapore, Singapore, 556741|