Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
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|ClinicalTrials.gov Identifier: NCT01797783|
Recruitment Status : Completed
First Posted : February 25, 2013
Results First Posted : May 23, 2014
Last Update Posted : May 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myopia Ametropia Presbyopia Refractive Error||Device: Nelfilcon A multifocal contact lens with comfort additive Device: Nelfilcon A multifocal contact lens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: DAILIES® AquaComfort Plus® Multifocal
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
|Device: Nelfilcon A multifocal contact lens with comfort additive|
Active Comparator: Focus® DAILIES® Progressives
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
|Device: Nelfilcon A multifocal contact lens|
- Subjective Overall Vision [ Time Frame: Up to Day 30 ]The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
- Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses [ Time Frame: Up to Day 30 ]Visual Acuity was tested while reading a chart at 20-foot equivalent distance from the participant with both eyes together. The Snellen fraction compares the participant's result to the result expected from the 'normal' visual system. The numerator represents the distance between the participant and the chart, and the denominator represents the distance at which a person with 'normal' vision would be able to discern the same letter size. 20/20 is considered to be 'normal' vision, whereas visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity.
- Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses [ Time Frame: Up to Day 30 ]Visual Acuity was tested while reading charts at a distance of 40 cm from the participant with both eyes together. The Snellen fraction 20/20 represents 'normal' near vision. A larger denominator indicates a lower visual acuity.
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): NCT01797783
|Study Director:||Justin Webb, O.D.||Alcon Research|