NCT02234700

Brief Summary

Comparison between patients with nasolacrimal duct obstruction and healthy patients and the influence of their bacterial flora on the corneal epithelium.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

6 months

First QC Date

August 26, 2014

Last Update Submit

September 8, 2014

Conditions

Acquired Nasolacrimal Duct Obstruction

Outcome Measures

Primary Outcomes (1)

  • the change of ocular normal flora in patients with nasolacrimal duct obstruction as a comparison to general population.

    as the literature suggests most of the ocular flora is composed of Staphylococcus and Haemophilus, any change in these composition will be considered abnormal.

    6 month

Eligibility Criteria

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

30 patients with nasolacrimal duct obstruction and 30 healthy patients

You may qualify if:

  • years of age or older, nasolacrimal duct obstruction

You may not qualify if:

  • younger then 18 years of age
  • ocular infections
  • patients after repair of lacrimal duct surgery
  • systemic active diseases
  • patients taking medication that are know to influence bacterial flora of the eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galileeh Hospital

Naharya, 22402, Israel

RECRUITING

Biospecimen

Retention: NONE RETAINED

Bacterial flora from the eye

Study Officials

  • Yanir Kassif, M.D

    Medical Center of the Galilee

    STUDY CHAIR

Central Study Contacts

abdelhakim Ayub, MD

CONTACT

0502999110abedayub@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2014

First Posted

September 9, 2014

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

IL(1)