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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00382681
• Collaborator: (none)
• Enrollment: 252
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 62.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Care	Device: FID 107027 Multi-Purpose Disinfecting Solution; Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Jul 1, 2004
• Actual Primary Completion Date: Nov 1, 2004
• Actual Study Completion Date: Nov 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FID 107027 Contact lens solution used as instructed for 90 days.	Device: FID 107027 Multi-Purpose Disinfecting Solution; Investigational, multi-purpose disinfecting solution intended for use in cleaning, rinsing, conditioning, disinfecting, and storing soft contact lenses.
Active Comparator: ReNu MultiPlus Contact lens solution used as instructed for 90 days.	Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula; Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Average Lens Wearing Time [Day 90]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elkin	Elkin	North Carolina	United States	28621

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Leslie Napier, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00382681
• Other Study ID Numbers: C-03-41
• First Posted: Sep 29, 2006
• Last Update Posted: Feb 2, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Alcon Research: Contact Lens Care
• Additional relevant MeSH terms: Pharmaceutical Solutions

Study Results

No Results Posted as of Feb 2, 2012