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

April 1, 2026 updated by: Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Cheryl Bayley
  • Phone Number: 5707145915

Study Locations

  • United States
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lacrifill
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dry eye signs
Time Frame: 2-3 months
To asses the effect of Lacrifill.
2-3 months
Dry Eye Symptoms
Time Frame: 2-3 Months
To asses the effect of Lacrifill.
2-3 Months
Contact Lens Tolerability
Time Frame: 2-3 Months
To asses the effect of Lacrifill.
2-3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate Changes in CLDEQ-8 Questionnaire
Time Frame: 2-3 Months
To assess the effect of Lacrifill
2-3 Months
Evaluate the Changes in the OSDI Questionnaire
Time Frame: 2-3 Months
To assess the effect of Lacrifill
2-3 Months
Evaluate changes in Contact Lens Wear Time
Time Frame: 2-3 Months
To assess the effect of Lacrifill
2-3 Months
Evaluate Clinical Signs of Tear Break Up Time
Time Frame: 2-3 Months
To assess the effect of Lacrifill
2-3 Months
Evaluate Clinical Signs of Corneal Staining
Time Frame: 2-3 Months
To assess the effect of Lacrifill
2-3 Months
Evaluate clinical Signs of Schirmer's Tear Test
Time Frame: 2-3 Months
To assess the effect of Lacrifill
2-3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Nordic Pharma, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAC-IST-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Unique study ID (no direct identifiers)

Demographic characteristics (e.g., age, sex, race/ethnicity)

Baseline clinical characteristics relevant to the study

Outcome data (primary and secondary endpoints)

Adverse events and serious adverse events

Concomitant medications

Intervention/exposure data

Follow-up assessments and visit dates

IPD Sharing Time Frame

12-2025 to 08-2026

IPD Sharing Access Criteria

We will provide source documents with the information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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