Evaluation of Lacrifill

Evaluation of Lacrifill Treatment for Alleviating Dry Eye Symptoms in Post-Operative Cataract Surgery Subjects

Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye; Ocular Surface Disease; Cataract Surgery; Eyes Dry Feeling of
• Intervention / Treatment: Drug: Lacrifill; Drug: Saline

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults ≥18 years of age.
• Have the potential of 20/40 visual acuity or better post-cataract surgery.
• have cataract surgery scheduled for both eyes
• Corneal staining score of ≥3 on the original National Eye Institute (NEI; 0-15 total score) staining scale in the study eye.
• willing to discontinue contact lens throughout the study?
• pre-treatment OSDI scores of ≤12 (asymptomatic)?

Exclusion Criteria:

• Known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)?
• History of ocular surgery within the past 12 months (excluding cataract surgery)
• Anticipated complications from cataract surgery in either eye?
• History of severe ocular trauma, active ocular infection or inflammation that is not dry eye-related?
• Used Accutane or is currently using ocular medications/treatments outside of study treatments? Artificial tears will be allowed.
• Physical meibomian gland treatment withing 1 month of enrollment?
• Having any conditions or are in a situation, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.
• Currently pregnant or breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lacrifill; Qualifying subjects will be treated with Lacrifill via the manufacturer's instructions	Drug: Lacrifill; Participants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage
Active Comparator: Saline/Standard of care; Qualifying subjects will be treated with saline via the manufacturer's instructions	Drug: Saline; Participants will be provided with a saline eye drop which is standard of care for those recovering from cataract surgery, and other complications that could cause symptoms related to Dry Eye Disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale)	Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.	1-month post operative compared to pre-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• OSDI Scores at the 3-month post-operative visit compared to pre-treatment (0-100 scale).	Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.	pre-treatment as compared to 3 months post operative.
Eye Dryness visual analog scale (VAS) Scores 1 month post operative	The Eye Dryness visual analog scale VAS will be conducted 1 month post operative with higher scores indicating more discomfort.	1 month post operative as compared to pre-treatment.
Eye Dryness visual analog scale (VAS) Scores 3 month post operative	The Eye Dryness visual analog scale VAS will be conducted 3 month post operative with higher scores indicating more discomfort.	3 month post operative as compared to pre-treatment.

Collaborators and Investigators

• Sponsor: Eye Research Associates, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: August 27, 2026
• First Submitted That Met QC Criteria: August 27, 2026
• First Posted (Actual): September 1, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: Lacrifill 101 IRB ID: 17131

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