Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
|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: NCT02939170|
Recruitment Status : Completed
First Posted : October 19, 2016
Results First Posted : January 23, 2018
Last Update Posted : July 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Refractive Error||Device: Delefilcon A Multifocal Contact Lenses with Molded Mark Device: Delefilcon A Multifocal Contact Lenses||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks|
|Actual Study Start Date :||November 14, 2016|
|Actual Primary Completion Date :||December 2, 2016|
|Actual Study Completion Date :||December 2, 2016|
Experimental: DT1 MF MM
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours
Device: Delefilcon A Multifocal Contact Lenses with Molded Mark
Active Comparator: DT1 MF
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
Device: Delefilcon A Multifocal Contact Lenses
Other Name: DAILIES TOTAL1® Multifocal (DT1 MF)
- Incidence of Ocular Discomfort Device-related Adverse Events (AE) [ Time Frame: Day 1 at Hour 9 ]An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.
- Ocular Staining [ Time Frame: Day 1 at Hour 9 ]Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.
- Limbal Hyperemia [ Time Frame: Day 1 at Hour 9 ]Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.
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): NCT02939170
|United States, Texas|
|Contact Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|
|Study Director:||Clinical Manager, CTM||Alcon, A Novartis Division|