Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lotrafilcon A contact lens; Device: Comfilcon A contact lens

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week
• Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses
• Replace lenses on a weekly or longer schedule
• Other protocol 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
• Current soft toric lens wearers
• Those who dispose of their soft lenses on a daily basis
• Current NIGHT & DAY® or Biofinity® lens wearers
• Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lotrafilcon A; Investigational, spherical, silicone hydrogel contact lenses	Device: Lotrafilcon A contact lens; Silicone hydrogel contact lens
Active Comparator: Comfilcon A; Commercially marketed, spherical, silicone hydrogel contact lenses	Device: Comfilcon A contact lens; Silicone hydrogel contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort at End of Day	Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.	After 4 weeks of wear

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (Estimated): December 18, 2008

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P-335-C-007