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

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lotrafilcon A Experimental Contact Lens; Device: Lotrafilcon A Commercial Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Lotrafilcon A Contact Lens; Lotrafilcon A experimental contact lens randomly assigned to one eye	Device: Lotrafilcon A Experimental Contact Lens; Experimental spherical, silicone hydrogel soft contact lens
Active Comparator: Commercial Lotrafilcon A Contact Lens; Lotrafilcon A commercial contact lens randomly assigned to one eye	Device: Lotrafilcon A Commercial Contact Lens; Commercially marketed spherical, silicone hydrogel soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Vision	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.	1 week

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: December 22, 2008
• First Submitted That Met QC Criteria: December 22, 2008
• First Posted (Estimated): December 23, 2008

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-335-C-009