Trial · NCT04418999
Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
NCT04418999, Early phase 1, Completed, Illinois College of Optometry; results first posted 2025-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus. Trials, record NCT04418999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04418999
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
- NCT number
- NCT04418999
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 36 participants, actual
- Lead sponsor
- Illinois College of Optometry
- Conditions
- Keratoconus, Dry Eye, Allergy
- Interventions
- dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use, Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
- First posted
- 2020-06-05
- Last updated
- 2026-06-24
- Results first posted
- 2025-04-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies | 90 days | 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) |
| Primary | Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity | 90 days | For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit. This outcome is measuring Osmolarity which is measured on a scale in units of milliosmoles. The scale measured is between 250-400 with the higher number being the worse score. |
| Primary | Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure | 90 days | For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit. This specific measure is measuring intraocular pressure by method of Goldman applanation tonometry. This is measured as a unit measure in units of mmHg between 10-22mmHg. |
| Primary | Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye | 90 days | For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit. tear-break-up time is measured on a scale of 0-4, the higher the number, the worse the score corneal staining is measured on a scale of 0-4, the higher the number the worse the score |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies | 90 days | 18 eyes per arm/group analyzed (36 eyes total/18 participants total) | papillary grade | MEAN |
| PRIMARY | Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity | 90 days | 18 eyes per arm/group | milliosmoles | MEAN |
| PRIMARY | Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure | 90 days | 18 eyes per arm/group | mmHg | MEAN |
| PRIMARY | Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye | 90 days | 18 eyes per arm/group | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies | Dexamethasone Insert | 1.67 | Standard Deviation 0.67 | papillary grade | |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies | Loteprednol Etabonate Ophthalmic Gel 0.38% | 2 | Standard Deviation 0.76 | papillary grade | |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity | Dexamethasone Insert | 297.8 | Standard Deviation 31.6 | milliosmoles | |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity | Loteprednol Etabonate Ophthalmic Gel 0.38% | 304.5 | Standard Deviation 21.6 | milliosmoles | |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure | Dexamethasone Insert | 14.7 | Standard Deviation 3.1 | mmHg | |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure | Loteprednol Etabonate Ophthalmic Gel 0.38% | 15.1 | Standard Deviation 3.1 | mmHg | |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye | Dexamethasone Insert | Tear Break-Up-Time (scale 0-4) | 3.4 | Standard Deviation 1.7 | score on a scale |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye | Loteprednol Etabonate Ophthalmic Gel 0.38% | Tear Break-Up-Time (scale 0-4) | 3.6 | Standard Deviation 1.8 | score on a scale |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye | Dexamethasone Insert | Corneal Staining (Scale 0-4) | 5.0 | Standard Deviation 2.2 | score on a scale |
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye | Loteprednol Etabonate Ophthalmic Gel 0.38% | Corneal Staining (Scale 0-4) | 5.2 | Standard Deviation 2.1 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexamethasone Insert | 18 | 18 |
| Overall Study | STARTED | Loteprednol Etabonate Ophthalmic Gel 0.38% | 18 | 18 |
| Overall Study | COMPLETED | Dexamethasone Insert | 18 | 18 |
| Overall Study | COMPLETED | Loteprednol Etabonate Ophthalmic Gel 0.38% | 18 | 18 |
| Overall Study | NOT COMPLETED | Dexamethasone Insert | 0 | 0 |
| Overall Study | NOT COMPLETED | Loteprednol Etabonate Ophthalmic Gel 0.38% | 0 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexamethasone Insert | 0 | 18 |
| Total, all-cause mortality | Loteprednol Etabonate Ophthalmic Gel 0.38% | 0 | 18 |
| Total, other adverse events | Dexamethasone Insert | 0 | 18 |
| Total, other adverse events | Loteprednol Etabonate Ophthalmic Gel 0.38% | 0 | 18 |
| Total, serious adverse events | Dexamethasone Insert | 0 | 18 |
| Total, serious adverse events | Loteprednol Etabonate Ophthalmic Gel 0.38% | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dexamethasone Insert vs Loteprednol Etabonate Ophthalmic Gel 0.38%: deaths from any cause | Trial comparisons |
| Dexamethasone Insert vs Loteprednol Etabonate Ophthalmic Gel 0.38%: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04418999
GET https://conductscience.org/api/trials/v1/NCT04418999/registered