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

Dry Eye Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684436
• Other study ID #: APMA-DE-0812
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2012
• Est. completion date: July 31, 2013

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2013
• Est. primary completion date: July 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• Punctal Plug
Punctal plugs inserted into the study eye on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Singapore, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Week 0 (Baseline)
Primary	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	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
Secondary	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
Secondary	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
Secondary	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