Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lotrafilcon A Commercial Contact Lens; Device: Lotrafilcon A Experimental Contact Lens

• Registration Number: NCT00813982
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2008-12-22
• Study First Posted: 2008-12-23
• Results First Submitted: 2010-09-03
• Results First Submitted QC: 2010-10-06
• Results First Posted: 2010-10-29
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-01
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
• On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses
• 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
• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
• Any active corneal infection
• Any use of medications for which contact lens wear would be contraindicated
• History of corneal refractive surgery
• Wears toric contact lenses
• Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Commercial Lotrafilcon A Contact Lens	Lotrafilcon A Commercial Contact Lens	Lotrafilcon A commercial contact lens randomly assigned to one eye
Experimental Lotrafilcon A Contact Lens	Lotrafilcon A Experimental Contact Lens	Lotrafilcon A experimental contact lens randomly assigned to one eye

Primary Outcome Measures

Name	Time	Method
Overall Vision	1 week	Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.