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Recruiting NCT07510620

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

Phase IV Interventional Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lacrifill.
Who it may be relevant to
Registry conditions: Dry Eye. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective, Single Arm Clinical Trial for the Treatment of Dry Eyes Signs and Symptoms in Patients With Limited Tolerability of Contact Lens Wear

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.

Interventions

  • 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.

Primary outcome measures

  • Dry eye signs [Time frame: 2-3 months]
  • Dry Eye Symptoms [Time frame: 2-3 Months]
  • Contact Lens Tolerability [Time frame: 2-3 Months]
Secondary outcome measures (6)
  • Evaluate Changes in CLDEQ-8 Questionnaire [Time frame: 2-3 Months]
  • Evaluate the Changes in the OSDI Questionnaire [Time frame: 2-3 Months]
  • Evaluate changes in Contact Lens Wear Time [Time frame: 2-3 Months]
  • Evaluate Clinical Signs of Tear Break Up Time [Time frame: 2-3 Months]
  • Evaluate Clinical Signs of Corneal Staining [Time frame: 2-3 Months]
  • Evaluate clinical Signs of Schirmer's Tear Test [Time frame: 2-3 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Eye Care Specialists — Kingston

Identifiers

NCT: NCT07510620 · LAC-IST-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗