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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 28, 2006
First Posted Date  ICMJE September 29, 2006
Last Update Posted Date February 2, 2012
Study Start Date  ICMJE July 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses [ Time Frame: Day 90 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 28, 2006)
  • Efficacy:
  • Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses
  • Safety:
  • Slit-lamp Findings - Cornea: Edema, Neovascularization, Staining, Infiltrates; Injection and Other Complications
  • Adverse Events
Change History Complete list of historical versions of study NCT00382681 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
Average Lens Wearing Time [ Time Frame: Day 90 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2006)
  • Subject Questions/Subject Likert Questionnaire
  • Lens Cleanliness
  • Lens Replacement Incidence and Causality
  • Corrected Visual Acuity with Study Lenses (Snellen)
  • Average Lens Wearing Time
  • Tarsal Conjunctiva Slit-lamp Findings
  • Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group I lenses
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of an Investigational Multi-Purpose Disinfecting Solution for Care of Soft Contact Lenses
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Contact Lens Care
Intervention  ICMJE
  • 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.
  • Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula
    Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses.
Study Arms  ICMJE
  • Experimental: FID 107027
    Contact lens solution used as instructed for 90 days.
    Intervention: Device: FID 107027 Multi-Purpose Disinfecting Solution
  • Active Comparator: ReNu MultiPlus
    Contact lens solution used as instructed for 90 days.
    Intervention: Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2006)
252
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Actual Primary Completion Date November 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00382681
Other Study ID Numbers  ICMJE C-03-41
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Leslie Napier Alcon Research
PRS Account Alcon Research
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP