NCT04413253

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

1.7 years

First QC Date

May 28, 2020

Last Update Submit

April 11, 2022

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

  • Mean change in ocular surface staining

    As measured by sodium fluorescein and lissamine green

    Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

  • Patient Preference for therapy

    As measured by COMTOL Survey

    Assessed at Week 12 Visit

Secondary Outcomes (7)

  • Mean change in MMP-9

    Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

  • Mean change in tear break-up time (TBUT)

    Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

  • Mean change in conjunctival injection

    Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

  • Change from baseline in meibomian gland scores (expressibility and quality)

    Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

  • Mean change in tear osmolarity

    Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

  • +2 more secondary outcomes

Study Arms (2)

Xiidra Only Group

ACTIVE COMPARATOR

Patients with dry eye disease Xiidra only

Drug: Lifitegrast 5% Ophthalmic Solution

Xiidra + Dextenza Group

EXPERIMENTAL

Patients with dry eye disease Xiidra + Dextenza

Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution

Interventions

Lifitegrast 5% Ophthalmic SolutionDRUG

To reduce signs and symptoms of dry eye disease

Also known as: Xiidra
Xiidra Only Group
Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic SolutionDRUG

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.

Also known as: Dextenza, Xiidra
Xiidra + Dextenza Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Surgeons of Indiana

Indianapolis, Indiana, 46040, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrastOphthalmic SolutionsCalcium Dobesilate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Damon Dierker, OD, FAAO

    Eye Surgeons of Indiana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 2, 2020

Study Start

August 1, 2020

Primary Completion

April 11, 2022

Study Completion

April 11, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Locations

US(1)