An Open Label Comparing the Short Term Efficacy of Lacrisert
Phase 4
- Conditions
- Dry Eye
- Interventions
- Drug: Lacrisert, 5 Mg Ophthalmic Insert
- Registration Number
- NCT03079271
- Lead Sponsor
- Virginia Eye Consultants
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description open label Lacrisert, 5 Mg Ophthalmic Insert -
- Primary Outcome Measures
Name Time Method Dry eye disease measured by Corneal Staining 10 days Dry eye disease measured by topographic results 10 days Dry Eye disease measured by OSDI questionnaire 10 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States