Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Narafilcon A contact lens; Device: Omafilcon A contact lens; Device: Nelfilcon A contact lens; Device: Etafilcon A contact lens; Device: Hilafilcon B contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00953407

P-337-C-027

Details and patient eligibility

About

The purpose of this trial is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

Enrollment: 128 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.
• Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.
• Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"
• Able to achieve VA of at least 20/40 in each eye with habitual correction and with study lenses at dispense.
• Other protocol inclusion/exclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks immediately prior to enrollment.
• Currently enrolled in any clinical trial.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• History of corneal refractive surgery.
• Cylinder correction greater than 1.00 D.
• Current monovision contact lens wearers.
• Other protocol inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 5 patient groups

Nelfilcon A

Experimental group

Description:

Nelfilcon A contact lens

Treatment:

Device: Nelfilcon A contact lens

Narafilcon A

Active Comparator group

Description:

Narafilcon A contact lens

Treatment:

Device: Narafilcon A contact lens

Etafilcon A

Active Comparator group

Description:

Etafilcon A contact lens

Treatment:

Device: Etafilcon A contact lens

Omafilcon A

Active Comparator group

Description:

Omafilcon A contact lens

Treatment:

Device: Omafilcon A contact lens

Hilafilcon B

Active Comparator group

Description:

Hilafilcon B contact lens

Treatment:

Device: Hilafilcon B contact lens