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

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.

Completed

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Key information

Conditions

Contact Lens Care

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elkin

Elkin, North Carolina, 28621, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FID 107027 Multi-Purpose Disinfecting Solution

Device

Investigational, multi-purpose disinfecting solution intended for use in cleaning, rinsing, conditioning, disinfecting, and storing soft contact lenses.

ReNu MultiPlus Multi-Purpose Solution No Rub Formula

Device

Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses.

Primary outcomes

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

Time frame: Day 90

Secondary outcomes

Average Lens Wearing Time

Time frame: Day 90

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses

Important dates

Study start: 2004
Primary completion: 2004
Study completion: 2004
First posted: Sep 29, 2006
Registry last updated: Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed