Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Official title:

Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04413253
• Other study ID #: The DAMON Study
• Status: Terminated
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: April 11, 2022

Study information

• Verified date: April 2022
• Source: Eye Surgeons of Indiana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 11, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Lifitegrast 5% Ophthalmic Solution
To reduce signs and symptoms of dry eye disease
• Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
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.

Locations

Country	Name	City	State
United States	Eye Surgeons of Indiana	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Eye Surgeons of Indiana	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient Preference for therapy	As measured by COMTOL Survey	Assessed at Week 12 Visit
Secondary	Mean change in MMP-9	As measure by InflammaDry	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Secondary	Mean change in tear break-up time (TBUT)	As measured by TBUT testing	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Secondary	Mean change in conjunctival injection	As measured on a scale of 0-4 and graded by the physician	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Secondary	Change from baseline in meibomian gland scores (expressibility and quality)	As measured on a grading scale 1 to 4 and graded by the physician	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Secondary	Mean change in tear osmolarity	As measured by Tear Lab	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Secondary	Mean change in DEQ-5	As measured by the DEQ-5 Questionnaire	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Secondary	Mean change in Best-corrected Visual Acuity (BCVA)	As measure by ETDRS	Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit