An Early Phase 1 interventional study of dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use and Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly in Keratoconus, Dry Eye and Allergy, sponsored by Illinois College of Optometry. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Illinois College of Optometry · Early Phase 1, Interventional, and Treatment
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%?
This prospective, open-label, single-center, randomized, fellow-eye, investigator-sponsored clinical study seeks to investigate the safety and efficacy of the dexamethasone insert in the treatment of allergic conjunctivitis and DED signs and symptoms in patients with Keratoconus using RGP contact lenses when compared to topical standard of care loteprednol etabonate ophthalmic gel 0.38%.
Patients with keratoconus who present for their routine visit who have signs and symptoms of dry eye and allergies, will be asked if they want to participate in the study. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, one eye will be randomized to receive the dexamethasone insert as determined by a coin flip at the screening visit. The remaining eye will be prescribed a loteprednol etabonate ophthalmic gel 0.38% following a 4,3,2,1 weekly taper. Per enrolled eye, the study period will last for approximately 90 days, consisting of five visits. At Screening/ Baseline, Day 0, Day 7, Day 30 and Day 90, primary and secondary endpoints will be assessed alongside standard-of-care procedures. Adjusting for enrollment period, the study will last a total of approximately 3 months
Inclusion Criteria
A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria
A patient who meets any of the following criteria will be excluded from the study:
Study Procedures Screening/Baseline (Visit 1)
After the patient has provided informed consent, the following information will be collected:
Insertion Visit/Day 0 (Visit 2)
Day 7 (Visit 3)
Day 30 (Visit 4)
Day 90 (Visit 5) or Early Termination
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 36 is close to the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Illinois College of Optometry is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum.
Drug: dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use
Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper
Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
Experimental
Also known as: Dextenza
Drug page: Loteprednol Etabonate
Active Comparator
Also known as: Lotemax
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies
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)
Time frame: 90 days
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity
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.
Time frame: 90 days
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure
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.
Time frame: 90 days
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye
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
Time frame: 90 days
| Milestone | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% |
|---|---|---|
| Started | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 0 |
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)
| papillary grade | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% |
|---|---|---|
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies | 1.67 ± 0.67 | 2 ± 0.76 |
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.
| milliosmoles | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% |
|---|---|---|
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity | 297.8 ± 31.6 | 304.5 ± 21.6 |
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.
| mmHg | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% |
|---|---|---|
| Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure | 14.7 ± 3.1 | 15.1 ± 3.1 |
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
| score on a scale | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% |
|---|---|---|
| Tear Break-Up-Time (scale 0-4) | 3.4 ± 1.7 | 3.6 ± 1.8 |
| Corneal Staining (Scale 0-4) | 5.0 ± 2.2 | 5.2 ± 2.1 |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone Insert | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Loteprednol Etabonate Ophthalmic Gel 0.38% | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
18 participants total one eye received dexamethasone insert; one eye received loteprednol etabonate ophthalmic gel
| Age, Categorical(eyes) | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 30 |
| >=65 years | 3 | 3 | 6 |
| Sex: Female, Male(Participants) | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 8 | 8 | 16 |
| Race (NIH/OMB)(Participants) | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 9 | 18 |
| White | 4 | 4 | 8 |
| More than one race | 5 | 5 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% | Total |
|---|---|---|---|
| United States | 18 | 18 | 18 |
| Count of eyes(eyes) | Dexamethasone Insert | Loteprednol Etabonate Ophthalmic Gel 0.38% | Total |
|---|---|---|---|
| Count of units | 18 | 18 | 36 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2020 to primary completion in Dec 2021, 15 months.
Results were first posted in Apr 2025, 3 years 3 months after primary completion.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Illinois College of Optometry