Evaluation of Lacrifill

Phase 4Not Yet RecruitingNCT07796178

Eye Research Associates, LLC40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Dry Eye Ocular Surface Disease Cataract Surgery Eyes Dry Feeling of

Interventions

LacrifillDRUG

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

SalineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1-month post operative compared to pre-treatment

Secondary Outcomes

• 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 month post operative as compared to pre-treatment.