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Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye

Primary Purpose

Dry Eye

Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Punctal Plug
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with moderate to severe dry eye

Exclusion Criteria:

  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Punctal plug

Arm Description

Punctal plugs inserted into the study eye on Day 1.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Corneal Fluorescein Staining Score in the Study Eye
The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition.
Tear Film Break-up Time (TBUT)
TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film.
Schirmer's Test Score
The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.
Dry Eye Questionnaire Irritation Score
Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms.

Full Information

First Posted
September 11, 2012
Last Updated
April 9, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01684436
Brief Title
Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2012 (Actual)
Primary Completion Date
July 31, 2013 (Actual)
Study Completion Date
July 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Punctal plug
Arm Type
Experimental
Arm Description
Punctal plugs inserted into the study eye on Day 1.
Intervention Type
Device
Intervention Name(s)
Punctal Plug
Intervention Description
Punctal plugs inserted into the study eye on Day 1.
Primary Outcome Measure Information:
Title
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye
Description
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.
Time Frame
Week 0 (Baseline)
Title
Concentration of Tear Cytokine Levels Following Punctal Plug Insertion in the Study Eye
Description
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.
Time Frame
Week 3
Secondary Outcome Measure Information:
Title
Corneal Fluorescein Staining Score in the Study Eye
Description
The cornea is evaluated following ocular administration of fluorescein stain in the study eye. The cornea is the transparent front part of the eye which covers the iris and pupil. The cornea is divided into 5 regions. Each region is scored according to the extent of staining, with scores ranging from 0 to 4 points: 0=non-staining to 4=regional whole staining of the cornea with 0.5 unit intervals. The higher the staining score, the worse the dry eye condition.
Time Frame
Week 0 (Baseline), Week 3
Title
Tear Film Break-up Time (TBUT)
Description
TBUT is defined as the time to initial breakup of the tear film following a blink. The longer it takes, the more stable the tear film.
Time Frame
Week 0 (Baseline), Week 3
Title
Schirmer's Test Score
Description
The Schirmer's Test measures the rate of tear secretion by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.
Time Frame
Week 0 (Baseline), Week 3
Title
Dry Eye Questionnaire Irritation Score
Description
Severity of dry eye irritation is rated by the patient using a visual analogue scale (VAS). Patients put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms. The higher the score, the more severe the symptoms.
Time Frame
Week 0 (Baseline), Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with moderate to severe dry eye Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
26774908
Citation
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.
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Safety and Efficacy of Punctal Plug Insertion in Patients With Dry Eye

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