Clinical Comparison of Two Daily Disposable Toric Lenses

Ciba Vision

Status: Completed

Conditions: Myopia; Astigmatism

Treatments: Device: etafilcon A contact lens; Device: nelfilcon A contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01362894

P-346-C-013

Details and patient eligibility

About

The purpose of this trial was to compare the performance of two contact lenses commercially available for people with astigmatism.

Full description

This trial compared the performance of two commercialized daily disposable contact lenses in Germany.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign written informed consent.
• Germany: Be of legal age.
• Current monthly or weekly toric soft lens wearer able to be fit in both eyes with soft toric lenses in the study parameters.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in an ophthalmic clinical trial.
• Wears contact lenses overnight while sleeping.
• Habitual daily disposable contact lens wearer.
• Monovision correction during the study.
• 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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240 participants in 2 patient groups

nelfilcon A / etafilcon A

Other group

Description:

Nelfilcon A lenses worn first, with etafilcon A 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: etafilcon A contact lens

etafilcon A / nelfilcon A

Other group

Description:

Etafilcon A lenses worn first, with nelfilcon A 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: etafilcon A contact lens