Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses

Alcon

Status: Completed

Conditions: Myopia; Refractive Error; Hyperopia

Treatments: Device: Nelfilcon A contact lenses; Device: Etafilcon A contact lenses; Device: Omafilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01839318

A01336

Details and patient eligibility

About

The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.

Full description

Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Enrollment: 30 patients

Sex: All

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign Informed Consent.
• Adapted soft contact lens wearer.
• Willing to wear contact lenses up to 12 hours and attend all study visits.
• Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
• Contact lens prescription within the power range specified in the protocol.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
• Any use of systemic or ocular medications that would contraindicate contact lens wear.
• Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
• Monocular (only 1 eye with functional vision) or fit with only 1 lens.
• History of herpetic keratitis, ocular surgery, or irregular cornea.
• Known pregnancy.
• Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
• Participation in any clinical study within 30 days of Visit 1.
• Other protocol-defined exclusion criteria may apply.

Trial design

30 participants in 3 patient groups

DAILIES AquaComfort Plus

Experimental group

Description:

Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.

Treatment:

Device: Nelfilcon A contact lenses

1-DAY ACUVUE MOIST

Active Comparator group

Description:

Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.

Treatment:

Device: Etafilcon A contact lenses

Proclear 1 day

Active Comparator group

Description:

Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours.

Treatment:

Device: Omafilcon A contact lenses