Performance Evaluation of a New Daily Disposable Silicone Hydrogel Lens (TUNGSTEN)

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: delefilcon A contact lens; Device: filcon II 3 contact lenses; Device: narafilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371552

P/319/08/C (Other Identifier)

P-371-C-100 v2

Details and patient eligibility

About

The purpose of this study was to compare a new daily disposable, silicone hydrogel contact lens to marketed daily disposable, silicone hydrogel contact lenses.

Full description

Part 1 of the study involved bilateral wear of three different types of marketed contact lenses. Each type of lens was worn for three consecutive days of daily disposable wear. Participants had been previously identified as symptomatic lens wearers or asymptomatic lens wearers, based upon their responses to a screening questionnaire. Participants wore each lens type for as long as they were comfortable during the day, but lenses were removed before sleep. After completion of Part 1, participants began Part 2, which included dispensing of the investigational study lens for up to one week of bilateral wear, with a single follow-up visit at the end of that period.

Enrollment: 119 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 17 years of age; full legal capacity to volunteer.
• Ocular examination within the last two years
• Correctable to a visual acuity of 20/30 or better (in each eye) with habitual vision correction.
• Currently wearing soft contact lenses.
• Clear corneas; no active ocular disease.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Currently wearing 1-DAY ACUVUE TruEye or Sauflon Clariti 1-DAY contact lenses.
• Monovision.
• Any ocular disease.
• Never worn contact lenses before.
• Corneal refractive surgery.
• Uses topical ocular medicine.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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119 participants in 3 patient groups

delefilcon A

Experimental group

Description:

Part 1: Delefilcon A contact lenses, followed by filcon II 3 contact lenses and narafilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.

Treatment:

Device: narafilcon A contact lenses

Device: filcon II 3 contact lenses

Device: delefilcon A contact lens

filcon II 3

Active Comparator group

Description:

Part 1: Filcon II 3 contact lenses, followed by narafilcon A contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.

Treatment:

Device: narafilcon A contact lenses

Device: filcon II 3 contact lenses

Device: delefilcon A contact lens

narafilcon A

Active Comparator group

Description:

Part 1: Narafilcon A contact lenses, followed by filcon II 3 contact lenses and delefilcon A contact lenses (in randomized order). Each product worn for three consecutive days, with a minimum 1-day washout between each product. At the conclusion of this wear cycle, the delefilcon A contact lenses were worn in Part 2 for one additional week. All products worn bilaterally in a daily wear, daily disposable modality.

Treatment:

Device: narafilcon A contact lenses

Device: filcon II 3 contact lenses

Device: delefilcon A contact lens