An Open Label Comparing the Short Term Efficacy of Lacrisert

Dry Eye Clinical Trial

Official title:

An Open Label Comparing the Short Term Efficacy of Lacrisert

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03079271
• Other study ID #: VEC-LAC001
• Status: Recruiting
• Phase: Phase 4
• First received: November 23, 2016
• Last updated: March 7, 2017
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Virginia Eye Consultants
• Contact: Jireh A
• Phone: 757-961-2950
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye

Intervention

Drug:
• Lacrisert, 5 Mg Ophthalmic Insert

Locations

Country	Name	City	State
United States	Virginia Eye Consultants	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Eye Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dry Eye disease measured by OSDI questionnaire		10 days
Primary	Dry eye disease measured by Corneal Staining		10 days
Primary	Dry eye disease measured by topographic results		10 days