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

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ClinicalTrials.gov Identifier: NCT00382681
Recruitment Status : Completed
First Posted : September 29, 2006
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
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.

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : July 2004
Actual Primary Completion Date : November 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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.




Primary Outcome Measures :
  1. Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses [ Time Frame: Day 90 ]

Secondary Outcome Measures :
  1. Average Lens Wearing Time [ Time Frame: Day 90 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00382681     History of Changes
Other Study ID Numbers: C-03-41
First Posted: September 29, 2006    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
Contact Lens Care

Additional relevant MeSH terms:
Pharmaceutical Solutions
Contact Lens Solutions
Disinfectants
Anti-Infective Agents