Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine efficacy and safety profile of dexamethasone 0.4mg lacrimal insert in dry eye related ocular surface inflammation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

• Male or Female Age 18-100

• Capacity to give informed consent

• Ability to follow study direction and complete all study visits

• A previous or current diagnosis of dry eye by an eye care specialist, whereas treatment is requiring the use of a topical steroid

• Able to have a lacrimal plug placement into both lower puncta. If lower puncta are already plugged or cauterized/sealed, upper puncta will be used

• Females of childbearing potential unwilling to use reliable form(s) of birth control throughout study period

• Clinical diagnosis of dry eye syndrome (DES) or keratoconjunctivitis sicca (KCS), in which the following has been bilaterally documented in the ophthalmic and medical histories:

i. history/diagnosis of dry eye ii. has taken or is on prescription drops (including but not limited to topical steroids, cyclosporine or lifitegrast)

• Presence of all of the following in both eyes at Baseline (Day 1):

i. Total OSS of 3 or more with at least 2+ corneal staining (0-6) ii. Unanesthetized Schirmer level of <10 mm at 5 minutes iii. Presence of significant symptoms defined as 30mm or higher score of (1) eye dryness, or (2) eye fatigue, or (3) eye discomfort as measured using VAS, in both eyes. At the baseline visit, the most bothersome symptom (of the three) will be determined and used as the main symptom outcome measure throughout the study.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

• Use of Contact lenses within 1 week of screening visit or during the study

• Any ocular surgery (including tear duct cauterization) within the 3 months

• Inability to place a lacrimal device into upper or lower puncta of both eyes (if upper in R eye should be upper in the left eye and vice versa)

• Inability to participate in the wash out period

• Use of topical glaucoma medications (With exception of rescue medication)

• Pregnancy, nursing or intention of pregnancy or nursing in the study period.

• Monocular patients

• Uncontrolled systemic disease (defined as frequent or recent change in the medication regimen)

• Patients who are currently on with stable doses of oral steroids, topical cyclosporine or lifitigrast, topical tacrolimus or pimecrolimus are eligible as long as there has been no change in the dose in the last 3 months

• Patients who are on topical steroids (With exception of rescue medication) (Patients who have used steroids recently but have been off for at least 2 weeks will be eligible.)

• Current enrollment in any other investigational drug or device study or participation of study within 30 days of baseline visit.

• Known allergy or sensitivity to any of the clinical or experimental drugs used in this study including history of steroid response.