Clinical Comparison of Two Daily Disposable Lenses Among Daily Disposable Lens Wearers

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: nelfilcon A; Device: filcon II 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT01134211

P-337-C-033

Details and patient eligibility

About

The primary objective of this trial is to evaluate the subjective performance of two different daily disposable contact lenses in a population of daily disposable lens wearers.

Enrollment: 316 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently wearing any spherical daily disposable lens in daily wear, daily disposable modality for at least 3 months prior to enrollment with the exception of the 2 study products
• Currently Wearing lenses at least 8 hrs/day and 5 days/week.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Prior history of corneal or refractive surgery.
• Requires monovision correction.
• 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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316 participants in 2 patient groups

nelfilcon A / filcon II 3

Other group

Description:

Nelfilcon A contact lenses worn first, with filcon II 3 contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.

Treatment:

Device: nelfilcon A

Device: filcon II 3

filcon II 3 / nelfilcon A

Other group

Description:

Filcon II 3 contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn in both eyes on a daily wear, daily disposable basis for one week each.

Treatment:

Device: nelfilcon A

Device: filcon II 3