An Open Label Comparing the Short Term Efficacy of Lacrisert

Virginia Eye Consultants

Status and phase: Unknown; Phase 4

Conditions: Dry Eye

Treatments: Drug: Lacrisert, 5 Mg Ophthalmic Insert

Study type: Interventional

Funder types: Other

Identifiers

NCT03079271

VEC-LAC001

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

open label

Other group

Treatment:

Drug: Lacrisert, 5 Mg Ophthalmic Insert