Daily Disposable Toric Comparative Trial in Europe

Ciba Vision

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: ocufilcon D contact lens; Device: nelfilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01070381

P-346-C-008

Details and patient eligibility

About

The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.

Enrollment: 220 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
• Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
• Achieve acceptable or optimal fit in each eye at time of dispense.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Habitual daily disposable contact lens wearer.
• Sleeps in contact lenses overnight.
• Currently enrolled in an ophthalmic clinical trial.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

nelfilcon A / ocufilcon D

Other group

Description:

Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Treatment:

Device: nelfilcon A contact lens

Device: ocufilcon D contact lens

ocufilcon D / nelfilcon A

Other group

Description:

Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.

Treatment:

Device: nelfilcon A contact lens

Device: ocufilcon D contact lens