Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

Sponsor
Eye Surgeons of Indiana (Other)
Overall Status
Terminated
CT.gov ID
NCT04413253
Collaborator
Ocular Therapeutix, Inc. (Industry)
5
1
2
20.3
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Study Details

Study Description

Brief Summary

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lifitegrast 5% Ophthalmic Solution
  • Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
Phase 4

Detailed Description

This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.

Study Design

Study Type:
Interventional
Actual Enrollment :
5 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Apr 11, 2022
Actual Study Completion Date :
Apr 11, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Xiidra Only Group

Patients with dry eye disease Xiidra only

Drug: Lifitegrast 5% Ophthalmic Solution
To reduce signs and symptoms of dry eye disease
Other Names:
  • Xiidra
  • Experimental: Xiidra + Dextenza Group

    Patients with dry eye disease Xiidra + Dextenza

    Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
    To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.
    Other Names:
  • Dextenza
  • Xiidra
  • Outcome Measures

    Primary Outcome Measures

    1. Mean change in ocular surface staining [Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit]

      As measured by sodium fluorescein and lissamine green

    2. Patient Preference for therapy [Assessed at Week 12 Visit]

      As measured by COMTOL Survey

    Secondary Outcome Measures

    1. Mean change in MMP-9 [Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit]

      As measure by InflammaDry

    2. Mean change in tear break-up time (TBUT) [Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit]

      As measured by TBUT testing

    3. Mean change in conjunctival injection [Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit]

      As measured on a scale of 0-4 and graded by the physician

    4. Change from baseline in meibomian gland scores (expressibility and quality) [Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit]

      As measured on a grading scale 1 to 4 and graded by the physician

    5. Mean change in tear osmolarity [Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit]

      As measured by Tear Lab

    6. Mean change in DEQ-5 [Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit]

      As measured by the DEQ-5 Questionnaire

    7. Mean change in Best-corrected Visual Acuity (BCVA) [Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit]

      As measure by ETDRS

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    • 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:
    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

    • 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 Eye Surgeons of Indiana Indianapolis Indiana United States 46040

    Sponsors and Collaborators

    • Eye Surgeons of Indiana
    • Ocular Therapeutix, Inc.

    Investigators

    • Principal Investigator: Damon Dierker, OD, FAAO, Eye Surgeons of Indiana

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eye Surgeons of Indiana
    ClinicalTrials.gov Identifier:
    NCT04413253
    Other Study ID Numbers:
    • The DAMON Study
    First Posted:
    Jun 2, 2020
    Last Update Posted:
    Apr 18, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 18, 2022