NCT01684436

Brief Summary

This study will access changes in tear protein levels and symptoms of dry eye following insertion of a punctal plug.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_4

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

September 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 15, 2014

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

September 11, 2012

Results QC Date

July 10, 2014

Last Update Submit

April 9, 2019

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

  • Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye

    A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.

    Week 0 (Baseline)

  • Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye

    A punctal plug (tear duct plug) is a device inserted into the tear duct (puncta) of the eye to block the tear duct from draining liquid from the eye. Tears were collected using the Schirmer's test strip. Tears are measured in the study eye for tear cytokine levels before punctal plug insertion in picogram(pg)/milliliter (mL)/millimeter (mm) of Schirmer's test strip moistened. Cytokines help with the generation of an immune response. Increased cytokine levels are representative of inflammation in the eye.

    Week 3

Secondary Outcomes (4)

  • Corneal Fluorescein Staining Score in the Study Eye

    Week 0 (Baseline), Week 3

  • Tear Film Break-up Time (TBUT)

    Week 0 (Baseline), Week 3

  • Schirmer's Test Score

    Week 0 (Baseline), Week 3

  • Dry Eye Questionnaire Irritation Score

    Week 0 (Baseline), Week 3

Study Arms (1)

Punctal plug

EXPERIMENTAL

Punctal plugs inserted into the study eye on Day 1.

Device: Punctal Plug

Interventions

Punctal PlugDEVICE

Punctal plugs inserted into the study eye on Day 1.

Punctal plug

Eligibility Criteria

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

You may qualify if:

  • Patients with moderate to severe dry eye

You may not qualify if:

  • Previous punctal plug insertion in the last 3 months or presence of plugs at the time of study
  • Contact lens wear in the 7 days prior to study start or during the study
  • LASIK procedure in the last year
  • Cataract or other eye surgery in the last 3 months
  • Corneal grafts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Singapore, Singapore

Location

Related Publications (1)

  • Tong L, Beuerman R, Simonyi S, Hollander DA, Stern ME. Effects of Punctal Occlusion on Clinical Signs and Symptoms and on Tear Cytokine Levels in Patients with Dry Eye. Ocul Surf. 2016 Apr;14(2):233-41. doi: 10.1016/j.jtos.2015.12.004. Epub 2016 Jan 13.

    PMID: 26774908BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Punctal Plugs

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 13, 2012

Study Start

October 1, 2012

Primary Completion

July 31, 2013

Study Completion

July 31, 2013

Last Updated

April 17, 2019

Results First Posted

August 15, 2014

Record last verified: 2019-04

Locations

SG(1)