Assessment of Lotrafilcon A Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lotrafilcon A upgrade soft contact lens

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months of wear, replacing lenses monthly

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months of wear, replacing lenses monthly

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 19, 2010
• First Posted (Estimate): August 20, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-335-C-015