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Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00382603
First received: September 28, 2006
Last updated: August 15, 2012
Last verified: September 2006
History of Changes

September 28, 2006
August 15, 2012
August 2004
February 2005   (final data collection date for primary outcome measure)
  • Efficacy:
  • Ocular Comfort and Symptom Scales
  • Subject Questions/Subject Likert Questionnaire
  • Safety:
  • Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
  • Adverse Events
Same as current
Complete list of historical versions of study NCT00382603 on ClinicalTrials.gov Archive Site
  • Corneal Fluorescein Staining (Type and Area)
  • Lens Surface Evaluation (Lens Deposit and Lens Wettability)
  • Lens Replacement Incidence and Causality
  • Corrected Visual Acuity with Study Lenses (Snellen)
  • Rewetting Drop Frequency
  • Lens Removal Frequency
  • Average Lens Wearing Time
  • Average Uncomfortable Lens Wearing Time
Same as current
Not Provided
Not Provided
 
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients
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 in Symptomatic Patients

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Contact Lens Care
Device: OptiFree Multi-Purpose Disinfecting Solution
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
362
February 2005
February 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptomatic for contact lens related discomfort at the end of the lens wearing day.
  • Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
  • 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 4 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00382603
C-04-09
Not Provided
Alcon Research
Alcon Research
Not Provided
Study Director: Leslie Napier Alcon Research
Alcon Research
September 2006

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