Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina - Full Text View

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00691457

Purpose

Three arm study comparing three novel contact lens solutions.

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

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	Other: Opti-Free contact lens solution Solution
Active Comparator: 2 ReNu Multiplus contact lens solution	Other: ReNu Multiplus contact lens solution Solution
Active Comparator: 3 Clear Care contact lens solution	Other: Clear Care contact lens solution Solution

Eligibility

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:	Dr. Ken Lebow O.D. FAAO, Independent
ClinicalTrials.gov Identifier:	NCT00691457 History of Changes
Other Study ID Numbers:	SMA-08-09
Study First Received:	June 3, 2008
Last Updated:	June 4, 2009
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 February 09, 2012