Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses

Phase 4RecruitingNCT07510620

Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye

Interventions

LacrifillDRUG

Lacrifill is a cross-linked hyaluronic acid derivative that temporarily blocks tear drainage, allowing patients eyed to be bathed in their own natural tears.

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ 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 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

Locations (1)

Eye Care Specialists

Kingston, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Dry eye signs

To asses the effect of Lacrifill.

Time frame: 2-3 months

Dry Eye Symptoms

To asses the effect of Lacrifill.

Time frame: 2-3 Months

Contact Lens Tolerability

To asses the effect of Lacrifill.

Time frame: 2-3 Months