CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Dextenza +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04168112
NCT04168112Phase 4Completed

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

Sight Medical Doctors PLLC·interventional·Posted Nov 19, 2019·Updated Jan 30, 2024

In Brief

A Phase 4 clinical trial evaluating Dextenza and Prednisolone Acetate for Keratoconus, Unstable and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 19, 2019
Enrollment StartFeb 12, 2020
Primary CompletionOct 24, 2022
Study CompletionApr 5, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.6 years ago

Interventions

Dextenzadrug

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

Prednisolone Acetatedrug

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