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

Primary Purpose

Keratoconus, Dry Eye, Allergy

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use
Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
Sponsored by
Illinois College of Optometry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Illinois Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexamethasone insert

Loteprednol etabonate ophthalmic gel 0.38%

Arm Description

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.

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

Outcomes

Primary Outcome Measures

To 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 OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, IOP will be taken at each visit
To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have 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

Secondary Outcome Measures

Full Information

First Posted
May 27, 2020
Last Updated
August 5, 2022
Sponsor
Illinois College of Optometry
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1. Study Identification

Unique Protocol Identification Number
NCT04418999
Brief Title
Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Illinois College of Optometry

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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%?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Dry Eye, Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone insert
Arm Type
Experimental
Arm Description
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.
Arm Title
Loteprednol etabonate ophthalmic gel 0.38%
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use
Other Intervention Name(s)
Dextenza
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly
Other Intervention Name(s)
Lotemax
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have allergies
Description
For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, IOP will be taken at each visit
Time Frame
90 days
Title
To determine the effect of dexamethasone intracanalicular insert on patients with keratoconus who also have dry eye
Description
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
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Illinois Eye Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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