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NCT04418999 · ClinicalTrials.gov registry record · Early Phase 1

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus

A Early Phase 1 study of Dry Eye and Keratoconus, sponsored by Illinois College of Optometry.

Completed
Registry status
Early Phase 1
Development phase
36
Enrollment target
1
Study location

NCT04418999 is a Early Phase 1 study of Dry Eye and Keratoconus that has completed, run by Illinois College of Optometry. The registered enrollment target is 36 participants, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04418999, a Early Phase 1 study of Dry Eye and Keratoconus, has completed, sponsored by Illinois College of Optometry.

COMPLETED
Registry status
Early Phase 1
Development phase
36 participants
Enrollment target
1
Study location

Study Summary

Drug delivery platforms are an innovative exciting advancement in ophthalmology. They allow patients to eliminate topical medications which are generally associated with lack of compliance, difficulty of use and requiring help from family members. These delivery systems can be applied easily in office, and patients do not have to worry about drop insertion in their post-operative regimen. The results of this research project should help to answer the following question: Does the use of a physician administered intracanalicular dexamethasone insert improve the signs and symptoms of ocular allergy and dry eye disease in KC patients compared to the use of topical loteprednol etabonate ophthalmic gel 0.38%?

Interventions

  • DRUG dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use
  • DRUG Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly

Study Locations (1)

Illinois

  • Illinois Eye Institute - Chicago

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2020-09-01
Est. Completion 2021-12-31
Phase Early Phase 1

Sponsor

Illinois College of Optometry

2 total trials

What the Registry Record Tells You About NCT04418999

The ClinicalTrials.gov registry entry for NCT04418999 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (62% lower). The listed sponsor is Illinois College of Optometry, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Dry Eye appearing as the primary indexed condition, and to 2 interventions - of which dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use is the first listed.

NCT04418999 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT04418999 about?

NCT04418999 is a clinical study titled "Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus". Drug delivery platforms are an innovative exciting advancement in ophthalmology. They allow patients to eliminate topical medications which are generally associated with lack of compliance, difficulty of use and requiring help from family members. These delivery systems can be applied easily in offi...

What is the current status of trial NCT04418999?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 36 participants. The study started on 2020-09-01. Estimated completion is 2021-12-31.

What conditions does trial NCT04418999 study?

This clinical trial studies the following conditions: Dry Eye, Keratoconus, Allergy.

What interventions are being tested in trial NCT04418999?

The interventions under investigation include: dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use (DRUG), Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly (DRUG).

Who is sponsoring clinical trial NCT04418999?

This trial is sponsored by Illinois College of Optometry, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04418999 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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