Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

Phase 4

Terminated

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Lifitegrast 5% Ophthalmic Solution; Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution

• Registration Number: NCT04413253
• Lead Sponsor: Eye Surgeons of Indiana

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.

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Study Start: 2020-08-01
• Status Verified: 2022-04
• Primary Completion: 2022-04-11
• Study Completion: 2022-04-11
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Xiidra Only Group	Lifitegrast 5% Ophthalmic Solution	Patients with dry eye disease Xiidra only
Xiidra + Dextenza Group	Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution	Patients with dry eye disease Xiidra + Dextenza

Primary Outcome Measures

Name	Time	Method
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
Patient Preference for therapy	Assessed at Week 12 Visit	As measured by COMTOL Survey

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
Mean change in MMP-9	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit	As measure by InflammaDry
Mean change in tear osmolarity	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit	As measured by Tear Lab
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

Trial Locations

Locations (1)

Eye Surgeons of Indiana; 🇺🇸 Indianapolis, Indiana, United States