KeratoconusEarly Phase 1NCT04418999
Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
A Early Phase 1 study testing dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use and Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly in people with Keratoconus and Dry Eye, run by Illinois College of Optometry at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Dry Eye, Allergy
- What is being tested?
- dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use and Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 31 Dec 2021
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Bilateral Keratoconus
- Bilateral RGP contact lenses
- Bilateral allergic conjunctivitis as determined by the Papillae Efron Scale score of at least 1 and symptoms of itching
- Bilateral underlying dry eye disease as determined by the NEI Fluorescein Staining Scale score of at least 1 and a TBUT of less than 10 and must correlate with dryness on OSDI
Who cannot join
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone
- Patients being treated with immunomodulating agents in the study eye(s)
- Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Intracanalicular Dexamethasone Insert Compared to Loteprednol Etabonate Ophthalmic Gel 0.38% in Patients With Keratoconus Wearing Gas Permeable Contact Lenses Who Have Been Diagnosed With Allergic Conjunctivitis
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%?
Read the detailed description
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:
- 18 years of age or older
- Bilateral Keratoconus
- Bilateral RGP contact lenses
- Bilateral allergic conjunctivitis as determined by the Papillae Efron Scale score of at least 1 and symptoms of itching
- Bilateral underlying dry eye disease as determined by the NEI Fluorescein Staining Scale score of at least 1 and a TBUT of less than 10 and must correlate with dryness on OSDI
Exclusion Criteria
A patient who meets any of the following criteria will be excluded from the study:
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone
- Patients being treated with immunomodulating agents in the study eye(s)
- Patients being treated with immunosuppressants and/or oral steroids Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Study Procedures Screening/Baseline (Visit 1)
After the patient has provided informed consent, the following information will be collected:
- Inclusion/Exclusion
- Demographics
- Medical History and Concurrent Illnesses
- Concomitant Medications
- Uncorrected and best-corrected visual acuity with manifest refraction as measured by ETDRS chart at 4 meters
- Ophthalmic Examination (with or without dilation)
- QOL assessment as measured by OSDI questionnaire
- Osmolarity (Needs to be done prior to any drop instillation)
- MMP9 (Needs to be done prior to any drop instillation)
- Grading of itching (scale 0-4)
- Papillae conjunctivitis assessment (Efron Scale)
- Conjunctival Injection
- Corneal Staining
- TBUT
- Intraocular Pressure
Insertion Visit/Day 0 (Visit 2)
- Concomitant Medications
- Uncorrected and best-corrected visual acuity with manifest refraction as measured by ETDRS chart at 4 meters
- Ophthalmic Examination (with or without dilation)
- QOL assessment as measured by OSDI questionnaire
- Osmolarity (Needs to be done prior to any drop instillation)
- MMP9 (Needs to be done prior to any drop instillation)
- Grading of itching (scale 0-4)
- Papillae conjunctivitis assessment (Efron Scale)
- Conjunctival Injection
- Corneal Staining
- TBUT
- Intraocular Pressure
- Insertion of Dextenza (intracanalicular dexamethasone insert)
- Insert Visualization
- Subject reported AEs after insertion
- Physician ease of insertion grading
Day 7 (Visit 3)
- Concomitant Medications
- Uncorrected and best-corrected visual acuity with manifest refraction as measured by ETDRS chart at 4 meters
- Ophthalmic Examination (with or without dilation)
- QOL assessment as measured by OSDI questionnaire
- Osmolarity (Needs to be done prior to any drop instillation)
- MMP9 (Needs to be done prior to any drop instillation)
- Grading of itching (scale 0-4)
- Papillae conjunctivitis assessment (Efron Scale)
- Conjunctival Injection
- Corneal Staining
- TBUT
- Intraocular Pressure
- Insert Visualization
- Subject reported AEs after insertion
Day 30 (Visit 4)
- Concomitant Medications
- Uncorrected and best-corrected visual acuity with manifest refraction as measured by ETDRS chart at 4 meters
- Ophthalmic Examination (with or without dilation)
- QOL assessment as measured by OSDI questionnaire
- Osmolarity (Needs to be done prior to any drop instillation)
- MMP9 (Needs to be done prior to any drop instillation)
- Grading of itching (scale 0-4)
- Papillae conjunctivitis assessment (Efron Scale)
- Conjunctival Injection
- Corneal Staining
- TBUT
- Intraocular Pressure
- Insert Visualization
- Subject reported AEs after insertion
Day 90 (Visit 5) or Early Termination
- Concomitant Medications
- Uncorrected and best-corrected visual acuity with manifest refraction as measured by ETDRS chart at 4 meters
- Ophthalmic Examination (with or without dilation)
- QOL assessment as measured by OSDI questionnaire
- Osmolarity (Needs to be done prior to any drop instillation)
- MMP9 (Needs to be done prior to any drop instillation)
- Grading of itching (scale 0-4)
- Papillae conjunctivitis assessment (Efron Scale)
- Conjunctival Injection
- Corneal Staining
- TBUT
- Intraocular Pressure
- Insert Visualization
- Subject reported AEs after insertion
- COMTOL
- Conditions
- Keratoconus, Dry Eye, Allergy
- Being tested
- dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use, Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
- Medical subject headings
- Keratoconus, Dry Eye Syndromes, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone ophthalmic insert 0.4 mg, for intracanalicular useDrug
Also called Dextenza
Experimental
Loteprednol Etabonate 0.38% Ophthalmic Gel/JellyDrug
Also called Lotemax
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone insert | Experimental | 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. Receives: Drug: dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use |
| Loteprednol etabonate ophthalmic gel 0.38% | Active comparator | 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 Receives: Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Sep 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illinois College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Harthan, Principal investigator, Illinois College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418999
- Sponsor's protocol ID
- 19027
- Status last verified
- Jun 2026
- First submitted
- 27 May 2020
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No