Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:7/4/2018
Start Date:November 14, 2016
End Date:December 2, 2016

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Trial Summary
Trial Overview
Inclusion Criteria
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).


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
1
site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas 76134
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mi
from
Fort Worth, TX
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