Evaluation of Lotrafilcon A Lenses Over a Three Month Period

Not Applicable

Completed

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

• Registration Number: NCT00931307
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this trial is to assess the performance of a Lotrafilcon A contact lens over a 3-month period.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-02
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Results First Submitted: 2010-09-16
• Results First Submitted QC: 2010-09-16
• Status Verified: 2010-10
• Results First Posted: 2010-10-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• On examination, have ocular findings considered to be "normal" and which would not prevent a subject 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 inclusion/exclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
• 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.
• Any use of medications for which contact lens wear would be contraindicated, in the opinion of the investigator.
• History of corneal refractive surgery.
• Other protocol 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	-

Primary Outcome Measures

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