Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

Not Applicable

Completed

• Conditions: Contact Lens Care

• Registration Number: NCT00382603
• 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 for soft contact lenses in patients who experience discomfort with their 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: 2006-09-29
• Last Update Submitted: 2012-08-15
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

• Symptomatic for contact lens related discomfort at the end of the lens wearing day.
• Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
• Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
• Successful lens wear for at least 4 hours per day.
• Vision correctable to 20/30.
• Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
• No corneal surgery within the past 12 months.
• No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
• No over-the-counter or prescription ocular medication.
• No enrollment in another clinical study within 30 days prior to enrollment.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy:
Ocular Comfort and Symptom Scales
Subject Questions/Subject Likert Questionnaire
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events

Secondary Outcome Measures

Name	Time	Method
Corneal Fluorescein Staining (Type and Area)
Lens Surface Evaluation (Lens Deposit and Lens Wettability)
Lens Replacement Incidence and Causality
Corrected Visual Acuity with Study Lenses (Snellen)
Rewetting Drop Frequency
Lens Removal Frequency
Average Lens Wearing Time
Average Uncomfortable Lens Wearing Time

Trial Locations

Locations (1)

Highlands Ranch; 🇺🇸 Highlands Ranch, Colorado, United States