NCT07648095

Brief Summary

This is a single-site observational study designed to evaluate the efficacy of Lacrifill™ canalicular filler in optimizing ocular surface parameters and biometric precision in prospective cataract surgery patients with dry eye disease (DED).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2027

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 9, 2026

Last Update Submit

June 12, 2026

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Mean absolute error (MAE)

    Difference in mean spherical equivalent Mean Absolute Error (MAE) between actual postoperative manifest refraction spherical equivalent and back-calculated equivalent based on baseline biometry.

    1 month postoperatively

Secondary Outcomes (4)

  • Difference in mean magnitude of postoperative refractive astigmatism

    1 month postoperatively

  • Lens type candidacy

    Preoperative assessment

  • Postoperative uncorrected visual acuity (logMAR)

    1 month postoperatively

  • Subjective visual satisfaction

    1 month postoperatively

Study Arms (1)

Lacrifill Canalicular Filler

Observational Study

Device: Lacrifill Canalicular Filler

Interventions

Lacrifill Canalicular FillerDEVICE

Lacrifill Canalicular Filler

Lacrifill Canalicular Filler

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects aged 40 years or older with diagnosed dry eye disease, totaling 65 eyes enrolled.

You may qualify if:

  • Age \>= 40 years
  • Diagnosed dry eye (OSDI \>= 13, TBUT \< 10 sec, or Oxford staining \>= Grade 2)
  • No recent ocular surgeries (\<6 months)
  • No significant changes in DED regimen within last 1 month

You may not qualify if:

  • Previous punctal plugs or canalicular cautery
  • Active ocular inflammation or corneal pathology unrelated to DED

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Eye Institute of West Florida

Largo, Florida, 33770, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Neel Desai, MD

    The Eye Institute of West Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renee Bondurant

CONTACT

727-450-4668Renee.Bondurant@eyespecialist.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2026

First Posted

June 15, 2026

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2027

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)