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

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00382902
Collaborator
(none)
233
Enrollment
1
Location
6
Duration (Months)
38.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: OptiFree Multi-Purpose Disinfecting Solution
 N/A

Study Design

Study Type:
Interventional
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 :
Aug 1, 2004
Actual Primary Completion Date :
Feb 1, 2005
Actual Study Completion Date :
Feb 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Portland Site Portland Maine United States 04101

Sponsors and Collaborators

  • Alcon Research

Investigators

  • Study Director: Leslie Napier, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00382902
Other Study ID Numbers:
  • C-04-13
First Posted:
Oct 2, 2006
Last Update Posted:
Aug 16, 2012
Last Verified:
Sep 1, 2006
Keywords provided by Alcon Research
Contact Lens Care

Study Results

No Results Posted as of Aug 16, 2012