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

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Lotrafilcon A Experimental Contact Lens; Device: Lotrafilcon A Commercial Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT00813982

P-335-C-009

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Experimental Lotrafilcon A Contact Lens

Experimental group

Description:

Lotrafilcon A experimental contact lens randomly assigned to one eye

Treatment:

Device: Lotrafilcon A Experimental Contact Lens

Commercial Lotrafilcon A Contact Lens

Active Comparator group

Description:

Lotrafilcon A commercial contact lens randomly assigned to one eye

Treatment:

Device: Lotrafilcon A Commercial Contact Lens