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Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study

NCT04168112 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-30

Study results available
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Summary

There is no standard of care medication regimen for the management of pain and inflammation post-corneal crosslinking (CXL), although most cornea specialists agree on use of an antibiotic and steroid eye drop in the immediate postoperative period. However, steroid tapering schedule and use of additional topical non-steroidal anti-inflammatory (NSAID) eyedrops vary amongst practitioners. The goal of this study is to compare postoperative pain scores between patients receiving a tapering dose of topical steroids over 1-month post-CXL, versus those receiving an intracanalicular dexamethasone insert.

Conditions

  • Keratoconus, Unstable
  • Collagen Crosslinking
  • Postoperative Pain

Interventions

DRUG

Dextenza

Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain

DRUG

Prednisolone Acetate

post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    collaborator INDUSTRY

  • Sight Medical Doctors PLLC

    lead OTHER

Principal Investigators

  • Alanna Nattis, DO · Sight Medical Doctors PLLC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2022-10-24
Completion
2023-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04168112 on ClinicalTrials.gov