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Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00383201
First received: September 28, 2006
Last updated: August 15, 2012
Last verified: September 2006
History of Changes
  Purpose

To clinically evaluate the effect of a new multi-purpose disinfecting solution compared to a marketed multi-purpose solution on wettability of soft contact lenses worn for 30 days.


Condition Intervention
Contact Lens Care
 Device: OptiFree Multi-Purpose Disinfecting Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Long-Term Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles of Soft Contact Lenses

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Efficacy:
  • Contact lens wetting angle measured ex-vivo
  • Safety:
  • Slit-lamp Findings: Eyelids and Conjunctiva; Cornea; Iris, Anterior Chamber
  • Visual Acuity (Snellen)
  • Adverse Events

Estimated Enrollment: 80
Study Start Date: March 2005
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • Successful daily wear of FDA Group I or IV soft contact lenses for at least one week.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383201

Locations
United States, Texas
Fort Worth Site
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Leslie Napier Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00383201     History of Changes
Other Study ID Numbers: C-05-01
Study First Received: September 28, 2006
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact Lens Care

ClinicalTrials.gov processed this record on May 22, 2013