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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00382902
First received: September 28, 2006
Last updated: August 15, 2012
Last verified: September 2006

September 28, 2006
August 15, 2012
August 2004
February 2005   (final data collection date for primary outcome measure)
  • Corneal Fluorescein Staining (Type and Area)
  • Conjunctival Staining
  • Lens Deposits
  • Subject Questions/Subject Likert Questionnaire
  • Ocular Comfort and Symptom Scales
  • Lens Replacement Incidence and Causality
  • Corrected Visual Acuity with Study Lenses (Snellen)
  • Average Lens Wearing Time
  • Average Uncomfortable Lens Wearing Time
  • 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 NCT00382902 on ClinicalTrials.gov Archive Site
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Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Silicone Hydrogel Soft Contact Lenses
Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to Two Marketed Multi-Purpose Solutions for Care of Silicone Hydrogel Soft Contact Lenses

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution in patients wearing silicone hydrogel soft contact lenses.

Not Provided
Interventional
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
233
February 2005
February 2005   (final data collection date for primary outcome measure)
  • Successful daily wear of Night & Day® or Acuvue® Advance™ silicone hydrogel contact for at least two weeks.
  • Use of AOSEPT® ClearCare™ only as the pre-study care regimen for at least two weeks (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.
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00382902
C-04-13
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