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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2013-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Punctal plug

Punctal plugs inserted into the study eye on Day 1.

Group Type EXPERIMENTAL

Punctal Plug

Intervention Type DEVICE

Punctal plugs inserted into the study eye on Day 1.

Interventions

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Punctal Plug

Punctal plugs inserted into the study eye on Day 1.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No