Pre-Lens Tear Film Performance of Silicone Hydrogel Daily Disposable Contact Lenses

Alcon

Status: Completed

Conditions: Myopia

Treatments: Device: Delefilcon A contact lens; Device: Narafilcon A contact lens; Device: Filcon II 3 contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01548833

A00924

Details and patient eligibility

About

The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be of legal age of consent and sign written Informed Consent document, or if under legal age, have written consent of parent or guardian to participate.
• Require vision correction in both eyes.
• Wear either daily disposable contact lenses or weekly/monthly replacement contact lenses in powers between -0.50 and -10.00 diopters, cylinder ≤0.75 diopter, no ADD correction.
• Wear habitual contact lenses an average of 12-14 hours per day, at least 5 days per week.
• Willing and able to wear study contact lenses 16 hours per day.
• Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Currently wearing DAILIES TOTAL1®, 1-DAY ACUVUE® TRUEYE™, or Clariti™ 1day contact lenses.
• Require monovision correction.
• Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye permitted), complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study.
• Ocular surgery/trauma within the last 6 months.
• Topical or systemic antibiotic use within 7 days of enrollment.
• Topical ocular or systemic corticosteroid use within 14 days of enrollment.
• Pregnant and nursing women.
• Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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39 participants in 3 patient groups

Dailies Total 1

Experimental group

Description:

Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Treatment:

Device: Filcon II 3 contact lens

Device: Narafilcon A contact lens

Device: Delefilcon A contact lens

TruEye

Active Comparator group

Description:

Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Treatment:

Device: Filcon II 3 contact lens

Device: Narafilcon A contact lens

Device: Delefilcon A contact lens

Clariti

Active Comparator group

Description:

Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner.

Treatment:

Device: Filcon II 3 contact lens

Device: Narafilcon A contact lens

Device: Delefilcon A contact lens