Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Early Phase 1 study of Dry Eye and Keratoconus, sponsored by Illinois College of Optometry.
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. According to ClinicalTrials.gov, the official US trial registry.
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%?
Primary Outcome
For patients with keratoconus who wear contact lenses and suffer with allergies Ocular Surface Disease Index (OSDI) questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and intraocular pressures (IOP) will be taken at each visit The primary outcome measure is papillary grade. This is measured on a grading scale of 0-4. Grade 0 is the lowest score, meaning no papillae are present. Grade 4 is the worse score. Papillary grade scale = 0-4 (grade 4 is worse score)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2021-12-31 |
| Phase | Early Phase 1 |
What the finished NCT04418999 record still lists
NCT04418999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 95-participant average among 41 other Dry Eye trials with a reported enrollment target (62% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Dry Eye
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04418999's enrollment target sits among peer trials
36 27th of 41 higher than 14 of 41 other Dry Eye trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy of Kera Sol Tears on Signs and Symptoms of Surgical Temporary Ocular Discomfort Syndrome (STODS) in Subjects Following LASIK
RECRUITING · Phase 4
-
The THINK Study Incidence of Neurotrophic Keratopathy)
RECRUITING · NA
-
Low Level Light Therapy & Skin Pigmentation
RECRUITING · NA
-
Quality of Life in Presbyopic Patients Who Are Treated With Qlosi
RECRUITING · Phase 4
-
A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye
RECRUITING · Phase 2
-
Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI