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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>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.
Disqualifiers
Known allergy to Hyaluronic Acid
Current topical ophthalmic drops other than dry eye treatment
Uncontrolled Diabetes
Diabetic Retinopathy
Trial design
Single group
Treatments tested in this trial
Lacrifill
DrugLacrifill is a cross-linked hyaluronic acid derivative that temporarily blocks tear drainage, allowing patients eyed to be bathed in their own natural tears.
Treatment groups
Trial outcomes
Primary outcomes
Dry eye signs
To asses the effect of Lacrifill.
Dry Eye Symptoms
To asses the effect of Lacrifill.
Contact Lens Tolerability
To asses the effect of Lacrifill.
Secondary outcomes
Evaluate Changes in CLDEQ-8 Questionnaire
To assess the effect of Lacrifill
Evaluate the Changes in the OSDI Questionnaire
To assess the effect of Lacrifill
Evaluate changes in Contact Lens Wear Time
To assess the effect of Lacrifill
Evaluate Clinical Signs of Tear Break Up Time
To assess the effect of Lacrifill
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists
Lead sponsor
Nordic Pharma, USA
Collaborator