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

Allergan

Status and phase: Completed; Phase 4

Conditions: Dry Eye

Treatments: Device: Punctal Plug

Study type: Interventional

Funder types: Industry

Identifiers

NCT01684436

APMA-DE-0812

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Punctal plug

Experimental group

Description:

Punctal plugs inserted into the study eye on Day 1.

Treatment:

Device: Punctal Plug