Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

Not Applicable

Completed

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

• Registration Number: NCT00810511
• Lead Sponsor: CIBA VISION

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2010-07-23
• Results First Submitted QC: 2010-09-09
• Results First Posted: 2010-10-01
• Status Verified: 2012-01
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lotrafilcon A	Lotrafilcon A contact lens	Investigational, spherical, silicone hydrogel contact lenses
Comfilcon A	Comfilcon A contact lens	Commercially marketed, spherical, silicone hydrogel contact lenses

Primary Outcome Measures

Name	Time	Method
Comfort at End of Day	After 4 weeks of wear	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.