NCT00724269

Brief Summary

The purpose of this study is to evaluate the corneal epithelium after soft contact lens wear and use of two marketed multi-purpose solutions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

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

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 1, 2012

Status Verified

November 1, 2011

Enrollment Period

1.7 years

First QC Date

July 25, 2008

Last Update Submit

September 28, 2012

Conditions

Contact Lens Wear

Keywords

Contact lens wearmulti-purpose solutioncorneal staining

Outcome Measures

Primary Outcomes (1)

  • Confocal microscopy analysis of Corneal Epithelium

    2 weeks

Secondary Outcomes (2)

  • Patient comfort

    2 weeks

  • Corneal Staining

    2 weeks

Study Arms (2)

Opti Free RepliniSH

ACTIVE COMPARATOR

Opti Free RepliniSH

Device: OPTI-FREE RepleniSH

ReNu Multi-Plus

ACTIVE COMPARATOR

ReNu Multi-Plus

Device: ReNu MultiPlus MPS

Interventions

OPTI-FREE RepleniSHDEVICE

Multi-Purpose Solution for soft contact lenses

Opti Free RepliniSH
ReNu MultiPlus MPSDEVICE

Multi-Purpose Solution for soft contact lenses

ReNu Multi-Plus

Eligibility Criteria

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

You may qualify if:

  • Successful contact lens wear on a daily wear basis
  • Wear contact lenses at least 8 hours/day
  • Vision correctable to at least 20/30
  • Normal Eyes

You may not qualify if:

  • Topical ocular medication use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Study Locations

Fort Worth, Texas, 76134, United States

Location

Study Design

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

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 1, 2012

Record last verified: 2011-11

Locations

US(1)