Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lotrafilcon A contact lens

• Registration Number: NCT00933166
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this trial is to assess the performance of an investigational contact lens over a three month period.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2010-12-02
• Results First Submitted QC: 2010-12-02
• Results First Posted: 2010-12-23
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.
• Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.
• 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.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks of enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in an ophthalmic clinical trial.
• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
• History of corneal refractive surgery.
• Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lotrafilcon A	Lotrafilcon A contact lens	Investigational contact lens worn in both eyes for three months

Primary Outcome Measures

Name	Time	Method
Comfort After Insertion	3 months	Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.