Evaluation of Lacrifill
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEye Research Associates, LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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?
Trial design
Design model
Parallel
Treatments tested in this trial
Lacrifill
DrugParticipants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage
Saline
DrugParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: LacrifillExperimental treatment 1 intervention
Group B: Saline/Standard of careActive comparator 1 intervention
Trial outcomes
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.
Time frame
1-month post operative compared to pre-treatmentSecondary outcomes
1
• 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.2
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. Scale 0-100 with score 0 representing No Symptoms and Score 100 representing Severe Symptoms.
Time frame
1 month post operative as compared to pre-treatment.3
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. Scale 0-100 with score 0 representing No Symptoms and Score 100 representing Severe Symptoms.
Time frame
3 month post operative as compared to pre-treatment.Sponsors and contacts
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Source ClinicalTrials.gov