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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04418999
- Acronym / sponsor ID
- 19027
- Conditions
- Keratoconus, Dry Eye, Allergy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Illinois College of OptometryUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Posted 6 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%?
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone insert | Experimental | Drug: dexamethasone ophthalmic insert 0.4 mg, for intracanalicular usePer 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. |
| Loteprednol etabonate ophthalmic gel 0.38% | Active comparator | Drug: Loteprednol Etabonate 0.38% Ophthalmic Gel/JellyPer 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone ophthalmic insert 0.4 mg, for intracanalicular useAlso: DextenzaExperimental | Drug | Dexamethasone insert |
| Loteprednol Etabonate 0.38% Ophthalmic Gel/JellyAlso: LotemaxActive Comparator | Drug | Loteprednol etabonate ophthalmic gel 0.38% |
Primary outcome
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies
Time frame: 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)
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity
Time frame: 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.
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure
Time frame: 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.
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Harthan principal investigator
Illinois College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies (time frame: 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.