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

Not Applicable

Completed

• Conditions: Contact Lens Care
• Interventions: Device: FID 107027 Multi-Purpose Disinfecting Solution; Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula

• Registration Number: NCT00382681
• 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2004-11
• Study Completion: 2004-11
• Study First Submitted: 2006-09-28
• Study First Submitted QC: 2006-09-28
• Study First Posted: 2006-09-29
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month.
• 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 8 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

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FID 107027	FID 107027 Multi-Purpose Disinfecting Solution	Contact lens solution used as instructed for 90 days.
ReNu MultiPlus	ReNu MultiPlus Multi-Purpose Solution No Rub Formula	Contact lens solution used as instructed for 90 days.

Primary Outcome Measures

Name	Time	Method
Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses	Day 90

Secondary Outcome Measures

Name	Time	Method
Average Lens Wearing Time	Day 90

Trial Locations

Locations (1)

Elkin; 🇺🇸 Elkin, North Carolina, United States