Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Silicone Hydrogel Soft Contact Lenses

Not Applicable

Completed

• Conditions: Contact Lens Care

• Registration Number: NCT00382902
• Lead Sponsor: Alcon Research

Brief Summary

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-02
• Study Completion: 2005-02
• Status Verified: 2006-09
• Study First Submitted: 2006-09-28
• Study First Submitted QC: 2006-09-28
• Study First Posted: 2006-10-02
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining (Type and Area)
Conjunctival Staining
Lens Deposits
Subject Questions/Subject Likert Questionnaire
Ocular Comfort and Symptom Scales
Lens Replacement Incidence and Causality
Corrected Visual Acuity with Study Lenses (Snellen)
Average Lens Wearing Time
Average Uncomfortable Lens Wearing Time
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events

Trial Locations

Locations (1)

Portland Site; 🇺🇸 Portland, Maine, United States