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

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ClinicalTrials.gov Identifier: NCT00382902
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : August 16, 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 in patients wearing silicone hydrogel soft contact lenses.

Condition or disease Intervention/treatment Phase
Contact Lens Care Device: OptiFree Multi-Purpose Disinfecting Solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 233 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2004
Actual Primary Completion Date : February 2005
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear




Primary Outcome Measures :
  1. Corneal Fluorescein Staining (Type and Area)
  2. Conjunctival Staining
  3. Lens Deposits
  4. Subject Questions/Subject Likert Questionnaire
  5. Ocular Comfort and Symptom Scales
  6. Lens Replacement Incidence and Causality
  7. Corrected Visual Acuity with Study Lenses (Snellen)
  8. Average Lens Wearing Time
  9. Average Uncomfortable Lens Wearing Time
  10. Safety:
  11. Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
  12. Adverse Events


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • 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.

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): NCT00382902


Locations
United States, Maine
Portland Site
Portland, Maine, United States, 04101
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Leslie Napier Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00382902     History of Changes
Other Study ID Numbers: C-04-13
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: September 2006

Keywords provided by Alcon Research:
Contact Lens Care

Additional relevant MeSH terms:
Pharmaceutical Solutions