NCT01250925

Brief Summary

The purpose of this study is to utilize in-vivo confocal microscopy to describe differences in corneal epithelial immune status across three lens care regimens in new contact lens wearers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

2 active sites

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

August 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

January 10, 2017

Completed
Last Updated

January 10, 2017

Status Verified

April 1, 2013

Enrollment Period

1.5 years

First QC Date

November 29, 2010

Results QC Date

April 24, 2013

Last Update Submit

November 11, 2016

Conditions

MyopiaRefractive Error

Keywords

Contact lensLens care

Outcome Measures

Primary Outcomes (10)

  • Corneal Epithelial Immune Dendritic Cell Density (Central Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Dendritic Cell Density (Inferior Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Dendritic Cell Density (Nasal Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Dendritic Cell Density (Superior Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Dendritic Cell Density (Temporal Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Non-Dendritic Cell Density (Central Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Non-Dendritic Cell Density (Inferior Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Non-Dendritic Cell Density (Nasal Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Non-Dendritic Cell Density (Superior Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

  • Corneal Epithelial Immune Non-Dendritic Cell Density (Temporal Cornea)

    The primary statistical objective is to describe differences in efficacy between regimens, specifically for measures of epithelial immune status. Immune status will be assessed via density of dendritic and non-dendritic immune cells.

    Six weeks

Secondary Outcomes (1)

  • Number of Participants With Slit-lamp Findings, Corrected Visual Acuity (Snellen) and Adverse Events

    Six weeks

Study Arms (3)

OPTI-FREE® RepleniSH®

ACTIVE COMPARATOR

33 participants will be assigned to use this lens care regimen during the six-week assessment period

Drug: OPTI-FREE® RepleniSH®

Clear Care®

ACTIVE COMPARATOR

33 participants will be assigned to use this lens care regimen during the six-week assessment period

Drug: Clear Care®

ReNu MultiPlus® MultiPurpose Solution

ACTIVE COMPARATOR

33 participants will be assigned to use this lens care regimen during the six-week assessment period

Drug: ReNu MultiPlus® MultiPurpose Solution

Interventions

ReNu MultiPlus® MultiPurpose SolutionDRUG

Contact lens care regimen

ReNu MultiPlus® MultiPurpose Solution
OPTI-FREE® RepleniSH®DRUG

Contact Lens care regimen

OPTI-FREE® RepleniSH®
Clear Care®DRUG

Contact lens care regimen

Clear Care®

Eligibility Criteria

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

You may qualify if:

  • Subjects must be 18 years of age and may be of any race and either gender.
  • Subjects must not have ever worn contact lenses.
  • Subjects must have normal, healthy eyes.

You may not qualify if:

  • Subjects must not use additional lens cleaners.
  • subjects must not have any ocular or systemic disease.
  • Subjects must not have history of ocular surgery/trauma within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242-1091, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

MyopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Dr. Pedram Hamrah
Organization
Massachusetts Eye and Ear Infirmary
cornea_research@meei.harvard.edu
617-573-3313

Study Officials

  • Pedram Hamrah, MD

    Massachusetts Eye and Ear Infirmary

    PRINCIPAL INVESTIGATOR

  • Christine Sindt, OD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2010

First Posted

December 1, 2010

Study Start

August 1, 2010

Primary Completion

February 1, 2012

Study Completion

July 1, 2012

Last Updated

January 10, 2017

Results First Posted

January 10, 2017

Record last verified: 2013-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)