NCT00691457

Brief Summary

Three arm study comparing three novel contact lens solutions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

October 1, 2012

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

June 3, 2008

Last Update Submit

September 28, 2012

Conditions

Contact Lens Solution

Keywords

Contact lenssolutionconfocal microscope

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in corneal fluorescein staining as evaluated at Day 30

    30 Days

Secondary Outcomes (1)

  • Confocal evaluation variables as measured at Days 0, 14, and 30

    Day 0, 14, 30

Study Arms (3)

1

EXPERIMENTAL

Opti-Free contact lens solution

Device: Opti-Free contact lens solution

2

ACTIVE COMPARATOR

ReNu Multiplus contact lens solution

Device: ReNu Multiplus contact lens solution

3

ACTIVE COMPARATOR

Clear Care contact lens solution

Device: Clear Care contact lens solution

Interventions

Opti-Free contact lens solutionDEVICE

Solution

1
ReNu Multiplus contact lens solutionDEVICE

Solution

2
Clear Care contact lens solutionDEVICE

Solution

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Beach, VA

Virginia Beach, Virginia, 23462, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 1, 2012

Record last verified: 2009-06

Locations

US(1)