Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT00691457

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2008

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in corneal fluorescein staining as evaluated at Day 30 [30 Days]

Secondary Outcome Measures

Confocal evaluation variables as measured at Days 0, 14, and 30 [Day 0, 14, 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Virginia Beach, VA	Virginia Beach	Virginia	United States	23462

Sponsors and Collaborators

Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00691457

Other Study ID Numbers:

SMA-08-09

First Posted:

Jun 5, 2008

Last Update Posted:

Oct 1, 2012

Last Verified:

Jun 1, 2009

Keywords provided by Alcon Research

Contact lens

solution

confocal microscope

Additional relevant MeSH terms:

Contact Lens Solutions

Pharmaceutical Solutions

Study Results

No Results Posted as of Oct 1, 2012