DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Delefilcon A contact lenses; Device: Somofilcon A contact lenses; Device: Narafilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT02517567

CLT978-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

Full description

This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign an informed consent document;
• Adapted, current soft contact lens wearer;
• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
• Can be successfully fitted with study lenses;
• Willing to wear lenses for a minimum of 8 hours prior to each study visit;
• Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
• Monocular (only 1 eye with functional vision) or fit with only one lens;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Known pregnancy and lactation;
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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37 participants in 4 patient groups

Sequence 1

Other group

Description:

Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.

Treatment:

Device: Narafilcon A contact lenses

Device: Somofilcon A contact lenses

Device: Delefilcon A contact lenses

Sequence 2

Other group

Description:

Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.

Treatment:

Device: Narafilcon A contact lenses

Device: Somofilcon A contact lenses

Device: Delefilcon A contact lenses

Sequence 3

Other group

Description:

Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.

Treatment:

Device: Narafilcon A contact lenses

Device: Somofilcon A contact lenses

Device: Delefilcon A contact lenses

Sequence 4

Other group

Description:

No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.

Treatment:

Device: Narafilcon A contact lenses

Device: Somofilcon A contact lenses

Device: Delefilcon A contact lenses