An Open Label Comparing the Short Term Efficacy of Lacrisert | NCT03079271

Studies
An Open Label Comparing the Short Term Efficacy of Lacrisert

NCT03079271

Sponsor

Virginia Eye Consultants

Status

Unknown status

Last Update Posted

Mar 14, 2017Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Dry Eye

Interventions

Lacrisert, 5 Mg Ophthalmic Insert

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 23, 2016

First Submission Date that Met QC Criteria

Mar 7, 2017

First Posted Date

Mar 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2017

Last Update Posted Date

Mar 14, 2017Actual

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
open label	Other		Drug: Lacrisert, 5 Mg Ophthalmic Insert

Name	Type	Description	Arm Group Labels	Other Names
Lacrisert, 5 Mg Ophthalmic Insert	Drug		open label

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dry Eye disease measured by OSDI questionnaire		10 days
Dry eye disease measured by Corneal Staining		10 days
Dry eye disease measured by topographic results		10 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jireh A	Contact	757-961-2950

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Eye Consultants	Recruiting	Norfolk	Virginia	23502	United States

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C008079	hydroxypropylcellulose

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided