Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00382681
First received: September 28, 2006
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Contact Lens Care
 Device: FID 107027 Multi-Purpose Disinfecting Solution
Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average Lens Wearing Time [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: July 2004
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382681

Locations
United States, North Carolina
Elkin
Elkin, North Carolina, United States, 28621
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Leslie Napier Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00382681     History of Changes
Other Study ID Numbers: C-03-41
Study First Received: September 28, 2006
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact Lens Care

ClinicalTrials.gov processed this record on May 19, 2013