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

Sponsor
Thomas Chester, OD (Other)
Overall Status
Completed
CT.gov ID
NCT04555694
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
16.5
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Cyclosporin
  • Drug: Loteprednol Etabonate
  • Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
 Phase 4

Study Design

Study Type:
Interventional
Actual 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 Restasis10 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 :
Oct 1, 2020
Actual Primary Completion Date :
Feb 16, 2022
Actual Study Completion Date :
Feb 16, 2022

Arms and Interventions

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 Names:
  • Restasis

    • Drug: Loteprednol Etabonate
    Used to treat inflammation of the eye
    Other Names:
  • 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 Names:
  • Restasis

    • Drug: Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert
    Used to treat inflammation of the eye
    Other Names:
  • 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 Names:
  • Restasis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean change in ocular surface staining [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 [Week 1 to week 12]

      Change in MMP-9 measured by InflammaDry

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

      Change in tear break-up time (TBUT)

    3. Mean change in conjunctival injection [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 [Week 1 to week 12]

      Meibomian gland scores through expression and quality

    5. Mean change in tear osmolarity [Week 1 to week 12]

      Change in tear osmolarity as measured by Tear Lab

    6. Mean change in DEQ-5 [Week 1 to week 12]

      Change in DEQ-5 as patient reported

    7. Mean change in Best-corrected Visual Acuity (BCVA [Week 1 to Week 12]

      Chnage in best-corrected visual acuity measured by ETDRS chart

    8. Mean change in Schirmer's score [Week 4 to Week 12]

      Change in Schirmer's score measured by Schirmer's test strip

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Cleveland Eye Clinic Brecksville Ohio United States 44141

    Sponsors and Collaborators

    • Thomas Chester, OD

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Chester, OD, Principal Investigator, Cleveland Eye Clinic
    ClinicalTrials.gov Identifier:
    NCT04555694
    Other Study ID Numbers:
    • TC-2020-DexRes
    First Posted:
    Sep 21, 2020
    Last Update Posted:
    May 11, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Loteprednol Etabonate
    Cyclosporine
    Dexamethasone
    Cyclosporins

    Study Results

    No Results Posted as of May 11, 2022