Skip to main content
OpenTrials
Completed

NCT Number: NCT04418999

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

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%?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Keratoconus Allergy Corneal Diseases Dry Eye Dry Eye Syndromes Eye Diseases Hypersensitivity Immune System Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Illinois Eye Institute

Chicago, Illinois, 60616, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use

Drug

Experimental

Other names: Dextenza

Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly

Drug

Active Comparator

Other names: Lotemax

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Illinois College of Optometry

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 5, 2020
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.