Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Habitual contact lens; Device: Lotrafilcon B contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01007916

P-336-C-016

Details and patient eligibility

About

The purpose of this study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.
• Wears lenses at least 5 days per week and at least 12 hours per day.
• Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.
• Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".
• Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.
• Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks prior to enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Currently sleeping in contact lenses for more than 6 consecutive nights.
• Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.
• Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Lotrafilcon B / Habitual

Other group

Description:

Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.

Treatment:

Device: Lotrafilcon B contact lens

Device: Habitual contact lens

Habitual / Lotrafilcon B

Other group

Description:

Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.

Treatment:

Device: Lotrafilcon B contact lens

Device: Habitual contact lens