Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus

NCT ID: NCT04418999

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-12-31

Brief 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%?

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dexamethasone insert

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.

Group Type: EXPERIMENTAL

dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use

Intervention Type: DRUG

Experimental

Loteprednol etabonate ophthalmic gel 0.38%

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

Group Type: ACTIVE_COMPARATOR

Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly

Intervention Type: DRUG

Active Comparator

Interventions

dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use

Experimental

Intervention Type: DRUG

Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly

Active Comparator

Intervention Type: DRUG

Other Intervention Names

Dextenza; Lotemax

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Illinois College of Optometry

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Harthan

Role: PRINCIPAL_INVESTIGATOR

Illinois College of Optometry

Locations

Illinois Eye Institute

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

19027

Identifier Type: -

Identifier Source: org_study_id