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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014