NCT00735865

Brief Summary

To determine if the types and amount of bacteria or other germs change over time after the routine procedure of blockage of tear drainage duct in the treatment of dry eye condition or other condition benefiting from a tear drainage blockage

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 25, 2009

Status Verified

May 1, 2009

Enrollment Period

5.8 years

First QC Date

August 13, 2008

Last Update Submit

May 22, 2009

Conditions

Dry Eye Syndrome

Keywords

Dry Eye SyndromePunctal OcclusionPunctal PlugsTear Drainage duct blockage

Outcome Measures

Primary Outcomes (1)

  • Impact of punctal occlusion on the ocular microbial flora

    1 year(3mo, 6mo, 12 mo culture/follow up visits)

Study Arms (4)

1

ACTIVE COMPARATOR
Procedure: Punctal plugs, punctal cautery

2

ACTIVE COMPARATOR
Procedure: Punctal Plug, Punctal thermocauterization

3

ACTIVE COMPARATOR
Procedure: Silicone plug or thermodynamic hydrophobic acrylic plug

4

ACTIVE COMPARATOR
Other: Previous subjects with Punctal occlusion

Interventions

Punctal plugs, punctal cauteryPROCEDURE

25 subjects(20 silicone punctal plugs, 5 punctal cautery) The procedure will be based on clinical indication. Randomized one eye for study. Baseline cultures of lid margin \& tarsal/inferior fornix conjunctiva obtained \& plated according to protocol

1
Punctal Plug, Punctal thermocauterizationPROCEDURE

Up to 5 subjects. Subjects in need of punctal occlusion(No preference for punctal thermocauterization or punctal occlusion by silicone plug). Randomize one eye to silicone punctal plug occlusion, the other eye to punctal thermocauterization. This group ONLY, cultures will be obtained of the lid margin \& conjunctiva/inferior fornix of BOTH eyes

2
Silicone plug or thermodynamic hydrophobic acrylic plugPROCEDURE

Up to 5 subjects. Subjects in need of punctal occlusion(not preference for punctal occlusion by silicone plug or by the thermodynamic hydrophobic acrylic plug). Randomize one eye to silicone punctal plug occlusion, the other eye to acrylic punctal plug occlusion. In this group ONLY cultures will be obtained of the lid margin and conjunctiva/inferior fornix of BOTH eyes

3
Previous subjects with Punctal occlusionOTHER

Up to 20 subjects(15 subjects with silicone punctal plug closure and 5 subjects with punctal closure by thermocauterization)Subjects who have previously had punctal occlusion who have symptoms and/or signs thought to be secondary to punctal occlusion. Lid margin and conjunctiva/inferior fornix of eye with greatest sign or symptoms will be cultured/plated according to standard protocol.

4

Eligibility Criteria

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

You may qualify if:

  • years and older
  • Able to sign Informed Consent
  • Clinical indication for punctal plug insertion or punctal cautery or symptomatic patients who have previously had punctal occlusion
  • Clinical indication for punctal plug removal(Partial extrusion, discomfort) increased signs of ocular irritation with punctate keratopathy, punctal inflammation).
  • Able to make follow up visit schedule

You may not qualify if:

  • Subjects without dry eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Lahey Clinic North

Peabody, Massachusetts, 01960, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Punctal Plugs

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Sarkis H. Soukiasian, M.D.

    Lahey Clinic, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

July 1, 2003

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

May 25, 2009

Record last verified: 2009-05

Locations

US(2)