Evaluation of Lacrifill

Part of paid clinical trials in Pittsburg, Kansas.

Sponsor
Eye Research Associates, LLC
Study ID
NCT07796178
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Sep 2, 2026
Status verified
Sep 2026
Primary completion
Dec 31, 2026
Completion
Feb 15, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Lacrifill
    Qualifying subjects will be treated with Lacrifill via the manufacturer's instructions
  • Active Comparator: Saline/Standard of care
    Qualifying subjects will be treated with saline via the manufacturer's instructions

Primary Outcome Measure

OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale) [ Time Frame: 1-month post operative compared to pre-treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Kannarr Eye CarePittsburgKansas66762
Shane Kannarr, OD
[email protected]
620-232-3277
Shane Kannarr, OD (PRINCIPAL_INVESTIGATOR)
Insight Eyecare Specialties IncKansas CityMissouri64111
Crystal Remington, OD
[email protected]
816-531-9100
Crystal Remington, OD (PRINCIPAL_INVESTIGATOR)

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By research site
Kannarr Eye Care· Pittsburg, KSInsight Eyecare Specialties Inc· Kansas City, MO

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