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Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00691457
First received: June 3, 2008
Last updated: September 28, 2012
Last verified: June 2009
History of Changes
  Purpose

Three arm study comparing three novel contact lens solutions.


Condition Intervention
Contact Lens Solution
 Device: Opti-Free contact lens solution
Device: ReNu Multiplus contact lens solution
Device: Clear Care contact lens solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

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:
  • Change from baseline in corneal fluorescein staining as evaluated at Day 30 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confocal evaluation variables as measured at Days 0, 14, and 30 [ Time Frame: Day 0, 14, 30 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Opti-Free contact lens solution
 Device: Opti-Free contact lens solution
Solution
Active Comparator: 2
ReNu Multiplus contact lens solution
 Device: ReNu Multiplus contact lens solution
Solution
Active Comparator: 3
Clear Care contact lens solution
 Device: Clear Care contact lens solution
Solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
  • Stable correction is defined as longer than six months.
  • Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months

Exclusion:

  • Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
  • Any systemic or ocular disease that could affect contact lens wear.
  • Women who are pregnant or lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691457

Locations
United States, Virginia
Virginia Beach, VA
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00691457     History of Changes
Other Study ID Numbers: SMA-08-09
Study First Received: June 3, 2008
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Contact lens
solution
confocal microscope

Additional relevant MeSH terms:
Contact Lens Solutions
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013