Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
Completed · Not applicable
Conditions studied: Refractive Error
In brief
The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).
Key facts
- Study ID
- NCT02939170
- Run by
- Alcon, a Novartis Company
- People needed
- 87
- Starts
- 2016-11-14
- Expected to finish
- 2016-12-02
- Last updated by the study team
- 2018-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Must sign an Informed Consent document;
- Current wearer of commercial DAILIES TOTAL1® contact lenses;
- Have spectacles in current prescription available to be worn in conjunction with the investigational product;
- Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
- Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;
- Other protocol-specified inclusion criteria may apply.
You may not qualify if…
- Eye injury in either eye within 12 weeks prior to study enrollment;
- Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- History of herpetic keratitis, refractive surgery or irregular cornea;
- A pathologically dry eye that precludes contact lens wear;
- Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
- Monocular (only 1 eye with functional vision);
- Other protocol-specified exclusion criteria may apply.
Where it is running
- Contact Alcon Call Center for Trial Locations — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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