Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease | NCT04413253

Studies
Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

NCT04413253

Sponsor

Eye Surgeons of Indiana

Status

Terminated

Last Update Posted

Apr 18, 2022Actual

Enrollment

5Actual

Phase

Phase 4

Conditions

Dry Eye Syndromes

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Unable to recruit

Expanded Access Info

Not provided

Start Date

Aug 1, 2020Actual

Primary Completion Date

Apr 11, 2022Actual

Completion Date

Apr 11, 2022Actual

First Submitted Date

May 28, 2020

First Submission Date that Met QC Criteria

May 28, 2020

First Posted Date

Jun 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2022

Last Update Posted Date

Apr 18, 2022Actual

Name	Class
Ocular Therapeutix, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Lifitegrast 5% Ophthalmic Solution	Drug	To reduce signs and symptoms of dry eye disease	Xiidra Only Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mean change in MMP-9	As measure by InflammaDry	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean change in tear break-up time (TBUT)	As measured by TBUT testing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Damon Dierker, OD, FAAO	Eye Surgeons of Indiana	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Eye Surgeons of Indiana		Indianapolis	Indiana	46040	United States

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 4, 2023			Oct 30, 2023	3
Jan 28, 2026

ID	Term
D015352	Dry Eye Syndromes

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
C575157	lifitegrast
D009883	Ophthalmic Solutions
D002123	Calcium Dobesilate

Ancestor Terms

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided