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Comparing Treatment of Dry Eye With Intracanlicular Dexamethasone, Restasis, and/or Lotemax

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ClinicalTrials.gov Identifier: NCT04555694
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Chester, OD, Cleveland Eye Clinic

Study Description
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Brief Summary:
This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Cyclosporin Drug: Loteprednol Etabonate Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 10 subjects will receive Restasis and Dextenza 10 subjects will receive Restasis and Lotemax 10 subjects will receive Restasis
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intracanalicular Dexamethasone Used in Conjunction With Restasis (Cyclosporine Ophthalmic Emulsion) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Restasis With Lotemax (Loteprednol Etabonate Ophthalmic Suspension 0.5%) and Restasis Monotherapy.
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Restasis and Lotemax
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes and Lotemax ophthalmic solution twice a day in both eyes.
 Drug: Cyclosporin
Used to increase tear production in patients who have dry eye caused by inflammation
Other Name: Restasis

Drug: Loteprednol Etabonate
Used to treat inflammation of the eye
Other Name: Lotemax
Active Comparator: Restasis and Dextenza
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes, as well as receiving Dextenza insertion in both lower lids.
 Drug: Cyclosporin
Used to increase tear production in patients who have dry eye caused by inflammation
Other Name: Restasis

Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
Used to treat inflammation of the eye
Other Name: Dextenza
Active Comparator: Restasis
10 subjects will be receiving Restasis ophthalmic solution twice a day in both eyes
 Drug: Cyclosporin
Used to increase tear production in patients who have dry eye caused by inflammation
Other Name: Restasis


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in ocular surface staining [ Time Frame: Week 1 to week 12 ]
    Mean change in ocular surface staining measured by the NEI grading scale


Secondary Outcome Measures :
  1. Mean change in MMP-9 [ Time Frame: Week 1 to week 12 ]
    Change in MMP-9 measured by InflammaDry

  2. Mean change in tear break-up time (TBUT) [ Time Frame: Week 1 to week 12 ]
    Change in tear break-up time (TBUT)

  3. Mean change in conjunctival injection [ Time Frame: Week 1 to week 12 ]
    Change in conjunctival injection measured on a scale of 0-4 and graded by physician

  4. Change from baseline in meibomian gland scores [ Time Frame: Week 1 to week 12 ]
    Meibomian gland scores through expression and quality

  5. Mean change in tear osmolarity [ Time Frame: Week 1 to week 12 ]
    Change in tear osmolarity as measured by Tear Lab

  6. Mean change in DEQ-5 [ Time Frame: Week 1 to week 12 ]
    Change in DEQ-5 as patient reported

  7. Mean change in Best-corrected Visual Acuity (BCVA [ Time Frame: Week 1 to Week 12 ]
    Chnage in best-corrected visual acuity measured by ETDRS chart

  8. Mean change in Schirmer's score [ Time Frame: Week 4 to Week 12 ]
    Change in Schirmer's score measured by Schirmer's test strip


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Signs and symptoms of DED
  • Consent to treat with topical immunomodulator
  • Willing and able to comply with clinic visits and study related procedures
  • Willing and able to sign the informed consent form

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
  • Altered nasolacrimal flow of either acquired, induced, or congenital origin
  • Hypersensitivity to dexamethasone
  • Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
  • Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
  • Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04555694


Contacts
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Contact: Erin Kus-Kreidler 216-503-6535 ekus-kreidler@clevelandeyeclinic.com
Contact: Jennifer Penny 440-526-1974 ext 354 jpenny@clevelandeyeclinic.com

Locations
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United States, Ohio
Cleveland Eye Clinic Recruiting
Brecksville, Ohio, United States, 44141
Contact: Erin Kus-Kreidler    216-503-6535    ekus-kreidler@clevelandeyeclinic.com   
Contact: Jennifer Penny    440-526-1974    jpenny@clevelandeyeclinic.com   
Sponsors and Collaborators
Thomas Chester, OD
More Information
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Responsible Party: Thomas Chester, OD, Principal Investigator, Cleveland Eye Clinic
ClinicalTrials.gov Identifier: NCT04555694    
Other Study ID Numbers: TC-2020-DexRes
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Loteprednol Etabonate
Cyclosporine
Dexamethasone
Cyclosporins
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents