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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Pharmaceutical Solutions
Contact Lens Solutions
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014