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Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

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ClinicalTrials.gov Identifier: NCT00691457
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
Three arm study comparing three novel contact lens solutions.

Condition or disease Intervention/treatment Phase
Contact Lens Solution Device: Opti-Free contact lens solution Device: ReNu Multiplus contact lens solution Device: Clear Care contact lens solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina
Study Start Date : April 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from baseline in corneal fluorescein staining as evaluated at Day 30 [ Time Frame: 30 Days ]

Secondary Outcome Measures :
  1. Confocal evaluation variables as measured at Days 0, 14, and 30 [ Time Frame: Day 0, 14, 30 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT00691457


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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00691457     History of Changes
Other Study ID Numbers: SMA-08-09
First Posted: June 5, 2008    Key Record Dates
Last Update Posted: October 1, 2012
Last Verified: June 2009

Keywords provided by Alcon Research:
Contact lens
solution
confocal microscope

Additional relevant MeSH terms:
Pharmaceutical Solutions
Contact Lens Solutions
Disinfectants
Anti-Infective Agents