Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses
Purpose
This research study is to see if using Lacrifill is safe, easy to use, and helpful for people who wear contact lenses but can't wear them comfortably for long. Specifically, the study aims to determine whether regular use of Lacrifill over a 2-3 month period can help people wear their contacts longer without discomfort and reduce signs and symptoms of dry eye.
Condition
- Dry Eye
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- >21 years of age - Contact lens wearer - Previous Dry Eye Treatment - Be on a stable dose of antihistamines/Birth Control Medication and Lifitegrast and cyclosporine. - Schrimers Anesthetized less than or equal to 10 - CLDEQ-8 greater than or equal to 12 - Corneal Staining NEI grading scale greater than or equal to 1
Exclusion Criteria
- Known allergy to Hyaluronic Acid - Current topical ophthalmic drops other than dry eye treatment - Uncontrolled Diabetes - Diabetic Retinopathy - Pregnancy or Lactating - Corneal Surgery (except Refractive) - Corneal Scars - Keratoconus - Ocular Herpetic Keratitis
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lacrifill |
|
Recruiting Locations
Eye Care Specialists
Kingston, Pennsylvania 18704
Kingston, Pennsylvania 18704
More Details
- Status
- Recruiting
- Sponsor
- Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists