Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

Eye Surgeons of Indiana

Status and phase

Terminated

Phase 4

Conditions

Dry Eye Syndromes

Treatments

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

Drug: Lifitegrast 5% Ophthalmic Solution

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT04413253

The DAMON Study

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Volunteers

No Healthy Volunteers

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