NCT01712022

Brief Summary

Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Consented subjects will undergo a series of cornea measurements using optical coherence tomography (OCT) that will be used for analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

3 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

October 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

October 19, 2012

Last Update Submit

September 9, 2014

Conditions

Dry Eye and Contact Lens Wear

Outcome Measures

Primary Outcomes (1)

  • corneal epithelial thickness

    Day 1

Study Arms (3)

Dry Eye

clinical diagnosis of dry eye

Contact Lens

routine wear of contact lens

Normal

Not having history of dry eye or contact lens wear or corneal pathology or surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

seeing eye doctor for routine or follow-up care

You may qualify if:

  • years of age or older
  • Able and willing to provide consent
  • Able and willing to complete the required examinations
  • DRY EYE GROUP ONLY: Clinical diagnosis of dry eye
  • CONTACT LENS GROUP ONLY: Regular contact lens wear

You may not qualify if:

  • History of ocular surgery
  • History of laser refractive surgery
  • History of cataract surgery
  • DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye
  • CONTACT LENS GROUP ONLY: Corneal pathology including dry eye
  • NORMAL GROUP ONLY: History of contact lens wear or dry eye or corneal pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fishman Vision

Palo Alto, California, 94301, United States

Location

Gordon-Weiss-Schanzlin Vision Institute

San Diego, California, 92122, United States

Location

Brass Eye Center

Latham, New York, 12110, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2012

First Posted

October 23, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations

US(3)