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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Device: Punctal Plug

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Punctal plug; Punctal plugs inserted into the study eye on Day 1.	Device: Punctal Plug; Punctal plugs inserted into the study eye on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 0 (Baseline), Week 3
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.	Week 0 (Baseline), Week 3
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.	Week 0 (Baseline), Week 3
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.	Week 0 (Baseline), Week 3

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2012
• Primary Completion (ACTUAL): July 31, 2013
• Study Completion (ACTUAL): July 31, 2013

Study Registration Dates

• First Submitted: September 11, 2012
• First Submitted That Met QC Criteria: September 11, 2012
• First Posted (ESTIMATE): September 13, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: APMA-DE-0812