RECRUITINGPhase 4INTERVENTIONAL
Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses
Prospective, Single Arm Clinical Trial for the Treatment of Dry Eyes Signs and Symptoms in Patients With Limited Tolerability of Contact Lens Wear
About This Trial
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.
Who May Be Eligible (Plain English)
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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Lacrifill
Lacrifill is a cross-linked hyaluronic acid derivative that temporarily blocks tear drainage, allowing patients eyed to be bathed in their own natural tears.
Locations (1)
Eye Care Specialists
Kingston, Pennsylvania, United States