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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01684436

Enrollment

Registered

2012-09-13

Start date

2012-10-01

Completion date

2013-07-31

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Brief summary

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

Interventions

DEVICEPunctal Plug

Punctal plugs inserted into the study eye on Day 1.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Concentration of Tear Cytokine Levels Before Punctal Plug Insertion in the Study Eye	Week 0 (Baseline)	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	Week 3	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

Measure	Time frame	Description
Corneal Fluorescein Staining Score in the Study Eye	Week 0 (Baseline), Week 3	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)	Week 0 (Baseline), Week 3	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	Week 0 (Baseline), Week 3	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	Week 0 (Baseline), Week 3	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.

Countries

Singapore

Participant flow

Participants by arm

Arm	Count
Punctal Plug Punctal plugs inserted into the study eye on Day 1.	29
Total	29

Baseline characteristics

Characteristic	Punctal Plug
Age, Continuous	49.8 Years STANDARD_DEVIATION 14.1
Sex: Female, Male Female	23 Participants
Sex: Female, Male Male	6 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 30
serious Total, serious adverse events	0 / 30

Outcome results

Primary

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.

Time frame: Week 0 (Baseline)