An Open Label Comparing the Short Term Efficacy of Lacrisert

NCT ID: NCT03079271

Last Updated: 2017-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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To evaluate the short term effects of LACRISERT®. upon fluorescein corneal staining, tear osmolarity and surface topography in human subjects with dry eye disease.

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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open label

Group Type OTHER

Lacrisert, 5 Mg Ophthalmic Insert

Intervention Type DRUG

Interventions

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Lacrisert, 5 Mg Ophthalmic Insert

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-Has Dry Eye disease indicated by a staining score of ≥ 4 and Speed score of \>6

Exclusion Criteria

* Concurrent involvement in any other clinical trial
* Anticipated contact lens wear during the study and 14hours prior to Day -History of corneal transplant
* Active ocular infection, uveitis or non-KCS inflammation
* History of recurrent herpes keratitis or active disease within the last six months
* Topical ophthalmic medications during the study
* Temporary collagen punctal plugs within one week prior to study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Eye Consultants

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jireh A

Role: CONTACT

757-961-2950

Facility Contacts

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jireh A, COA

Role: primary

757-961-2947

Other Identifiers

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VEC-LAC001

Identifier Type: -

Identifier Source: org_study_id

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