Back to resultsAn Open Label Comparing the Short Term Efficacy of Lacrisert
Primary Purpose
Dry Eye
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lacrisert, 5 Mg Ophthalmic Insert
Sponsored by
About this trial
This is an interventional supportive care trial for Dry Eye
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.
Sites / Locations
- Virginia Eye ConsultantsRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
open label
Arm Description
Outcomes
Primary Outcome Measures
Dry Eye disease measured by OSDI questionnaire
Dry eye disease measured by Corneal Staining
Dry eye disease measured by topographic results
Secondary Outcome Measures
Full Information
NCT ID
NCT03079271
First Posted
November 23, 2016
Last Updated
March 7, 2017
Sponsor
Virginia Eye Consultants
1. Study Identification
Unique Protocol Identification Number
NCT03079271
Brief Title
An Open Label Comparing the Short Term Efficacy of Lacrisert
Official Title
An Open Label Comparing the Short Term Efficacy of Lacrisert
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Eye Consultants
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
open label
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Lacrisert, 5 Mg Ophthalmic Insert
Primary Outcome Measure Information:
Title
Dry Eye disease measured by OSDI questionnaire
Time Frame
10 days
Title
Dry eye disease measured by Corneal Staining
Time Frame
10 days
Title
Dry eye disease measured by topographic results
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jireh A
Phone
757-961-2950
Facility Information:
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jireh A, COA
Phone
757-961-2947
First Name & Middle Initial & Last Name & Degree
John D Sheppard, M.D.
12. IPD Sharing Statement
Learn more about this trial
An Open Label Comparing the Short Term Efficacy of Lacrisert
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