Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Lotrafilcon A contact lens; Device: Narafilcon A contact lens; Device: Galyfilcon A contact lens

• Registration Number: NCT00934102
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Study Start: 2009-08
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-11
• Results First Submitted: 2010-11-01
• Results First Submitted QC: 2010-11-01
• Results First Posted: 2010-12-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Is at least 17 years of age and has full legal capacity to volunteer
• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
• Has had an ocular examination in the last two years
• Is a current soft (hydrogel or silicone hydrogel) contact lens wearer
• Has clear corneas and no active ocular disease
• Can be successfully fit with the lenses to be used in the study
• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria

• Is pregnant or lactating
• Has undergone corneal refractive surgery
• Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study
• 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	Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Narafilcon A	Narafilcon A contact lens	Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.
Galyfilcon A	Galyfilcon A contact lens	Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis.

Primary Outcome Measures

Name	Time	Method
Front Surface Lens Deposits	Period 2, Day 6	Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.

Trial Locations

Locations (1)

Centre for Contact Lens Research: University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada