Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

Not Applicable

Completed

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

• Registration Number: NCT00808834
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-11
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-16
• Results First Submitted: 2010-06-18
• Results First Submitted QC: 2010-09-16
• Results First Posted: 2010-10-04
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Currently wearing soft contact lenses
• Replaces lenses on a weekly or longer schedule
• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria

• Requires concurrent ocular medication
• Eye injury or surgery within twelve weeks immediately prior to enrollment
• Currently wearing soft toric lens wearers
• Those who dispose of their soft lenses on a daily basis
• Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Senofilcon A / Lotrafilcon A	Lotrafilcon A contact lens	Senofilcon A, followed by Lotrafilcon A
Senofilcon A / Lotrafilcon A	Senofilcon A contact lens	Senofilcon A, followed by Lotrafilcon A
Lotrafilcon A / Senofilcon A	Lotrafilcon A contact lens	Lotrafilcon A, followed by Senofilcon A
Lotrafilcon A / Senofilcon A	Senofilcon A contact lens	Lotrafilcon A, followed by Senofilcon A

Primary Outcome Measures

Name	Time	Method
Comfort After Insertion	30-60 seconds after initial insertion	Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.