Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Delefilcon A Multifocal Contact Lenses with Molded Mark; Device: Delefilcon A Multifocal Contact Lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02939170

CLO870-C001

Details and patient eligibility

About

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).

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 2 patient groups

DT1 MF MM

Experimental group

Description:

Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours

Treatment:

Device: Delefilcon A Multifocal Contact Lenses with Molded Mark

DT1 MF

Active Comparator group

Description:

Delefilcon A multifocal contact lenses worn bilaterally for 9 hours

Treatment:

Device: Delefilcon A Multifocal Contact Lenses