Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

Phase 4TerminatedNCT04413253

Eye Surgeons of Indiana5 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye Syndromes

Interventions

Lifitegrast 5% Ophthalmic SolutionDRUG

To reduce signs and symptoms of dry eye disease

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Eye Surgeons of Indiana

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Mean change in ocular surface staining

As measured by sodium fluorescein and lissamine green

Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

Patient Preference for therapy

As measured by COMTOL Survey

Time frame: Assessed at Week 12 Visit

Secondary Outcomes

Mean change in MMP-9

As measure by InflammaDry

Time frame: 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

Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

Mean change in conjunctival injection

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

Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

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

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

Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

Mean change in tear osmolarity

As measured by Tear Lab

Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit

Mean change in DEQ-5

As measured by the DEQ-5 Questionnaire

Data from ClinicalTrials.gov

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