Assessment of Lotrafilcon A Contact Lenses

N/ACompletedNCT01185834

CIBA VISION118 enrolled

Overview

The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

118

Conditions

Myopia

Interventions

Lotrafilcon A upgrade soft contact lensDEVICE

Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Have normal ocular findings. * Be able to wear the study lenses in the available powers. * Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day. * Wear Night \& Day contact lenses. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Require concurrent ocular medication. * Eye injury or surgery within twelve weeks prior to enrollment. * Currently enrolled in an ophthalmic clinical trial. * Any active corneal infection. * Corneal refractive surgery. * Wear AIR OPTIX NIGHT \& DAY AQUA lenses. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Overall Comfort

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Time frame: 3 months of wear, replacing lenses monthly

Secondary Outcomes

Overall Lens Fit

As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight

Time frame: 3 months of wear, replacing lenses monthly

Data from ClinicalTrials.gov

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