Expired Study
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Virginia Beach, Virginia 23462


Purpose:

Three arm study comparing three novel contact lens solutions.


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.


Study is Available At:


Original ID:

SMA-08-09


NCT ID:

NCT00691457


Secondary ID:


Study Acronym:


Brief Title:

Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina


Official Title:

Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alcon Research


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Study Dates

Start Date:April 2008
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:January 2009
Primary Completion Type:Actual
Verification Date:June 2009
Last Changed Date:September 28, 2012
First Received Date:June 3, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Confocal evaluation variables as measured at Days 0, 14, and 30
Time Frame:Day 0, 14, 30
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change from baseline in corneal fluorescein staining as evaluated at Day 30
Time Frame:30 Days
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Opti-Free contact lens solution
Description:Solution
Arm Name:1
Intervention Type:Device
Name:ReNu Multiplus contact lens solution
Description:Solution
Arm Name:2
Intervention Type:Device
Name:Clear Care contact lens solution
Description:Solution
Arm Name:3

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Opti-Free contact lens solution
Study Arm Type:Active Comparator
Arm Name:2
Description:ReNu Multiplus contact lens solution
Study Arm Type:Active Comparator
Arm Name:3
Description:Clear Care contact lens solution

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Alcon Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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