Initial Performance of a Modified Daily Disposable Contact Lens

Alcon

Status

Completed

Conditions

Refractive Error

Treatments

Device: Delefilcon A contact lenses

Device: Delefilcon A contact lenses with UV Absorber

Study type

Interventional

Funder types

Industry

Identifiers

NCT02694835

CLP691-C001

Details and patient eligibility

About

The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must sign an Informed Consent document;
Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
Manifest astigmatism less than or equal to 0.75 D (at screening);
Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
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 as determined by the Investigator;
Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
History of herpetic keratitis;
History of refractive surgery or irregular cornea;
Pathologically dry eye that precludes contact lens wear;
Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
Monocular (only 1 eye with functional vision);
Other protocol-specified exclusion criteria may apply.