Evaluation of Lacrifill

NCT07796178 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: Lacrifill 101 IRB ID: 17131
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dry Eye; Ocular Surface Disease; Cataract Surgery; Eyes Dry Feeling of

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• • OSDI Scores at the 3-month post-operative visit compared to pre-treatment (0-100 scale).

  pre-treatment as compared to 3 months post operative.

• Eye Dryness visual analog scale (VAS) Scores 1 month post operative

  1 month post operative as compared to pre-treatment.

• Eye Dryness visual analog scale (VAS) Scores 3 month post operative

  3 month post operative as compared to pre-treatment.

Study Arms (2)

Lacrifill

EXPERIMENTAL

Qualifying subjects will be treated with Lacrifill via the manufacturer's instructions

Drug: Lacrifill

Saline/Standard of care

ACTIVE COMPARATOR

Qualifying subjects will be treated with saline via the manufacturer's instructions

Drug: Saline

Interventions

Lacrifill DRUG

Participants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage

Lacrifill

Saline DRUG

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.

Saline/Standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)?

You may not qualify if:

• 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

Sponsors & Collaborators

• Eye Research Associates, LLC: lead

Study Sites (2)

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

RECRUITING

Insight Eyecare Specialties Inc

Kansas City, Missouri, 64111, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Principal Investigator who is completing the assessments will be masked in order to prevent biasing the study. An unmasked coordinator not involved in the assessment portion of the study will provide information to the study participant regarding the treatment and be in charge of the randomziation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to either the Lacrifill group or the saline/standard of care. After eligibility requirements are meant.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 1, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

US (2)