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

NCT ID: NCT04498468

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2023-03-03

Brief Summary

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

Detailed Description

Previous studies showed that dexamethasone and loteprednol topical drops have led to favorable results. However, the requirement of frequent instillation of drops by the patients is problematic causing discomfort and blurring of vision and requires remembering and dexterity for instillation, poor compliance is not uncommon. In addition Investigators believe that instillation of drops disturbs the homeostasis of the natural tear film due to physical and chemical trauma due to large drop volume (50 microliters) hammering on the eye surface (which can only hold 7 to 10 microliters). Particularly washing away of the mucin layer that holds all the "good ingredients" in the tears is harmful to the ocular surface. Therefore, "dropless" treatment of dry eye is desirable.

Dextenza® (dexamethasone ophthalmic insert, Ocular Therapeutix Inc., Bedford, MA) is a corticosteroid intracanalicular insert approved by US-FDA in November 2018 for the treatment of post-surgical ocular inflammation and pain. It is inserted into the lower lacrimal punctum and into the canaliculus. A single insert releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. Dextenza® is resorbable and does not require removal. Investigators hypothesize that Dextenza® could mimic short-term topical steroid use in a tapering manner in patients with clinically significant dry eye and show efficacy in improving its symptoms and signs, as was previously shown with other steroid preparations. If proven, the use of Dextenza® may shift paradigms in the management of the clinically significant ocular surface disease. To test this hypothesis, investigators propose to study the effects of Dextenza® in the treatment of clinically significant dry eye.

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Arm

Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)

Group Type: EXPERIMENTAL

Sustained Release Dexamethasone, 0.4 mg

Intervention Type: DRUG

dexamethasone 0.4mg lacrimal insert

Control Arm

Commercially available EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL) (Vera90™ - Elkridge, MD)

Group Type: SHAM_COMPARATOR

E-Caprolactone-L-Lactide copolymer (PCL) punctal plug

Intervention Type: OTHER

Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)

Interventions

Sustained Release Dexamethasone, 0.4 mg

dexamethasone 0.4mg lacrimal insert

Intervention Type: DRUG

E-Caprolactone-L-Lactide copolymer (PCL) punctal plug

Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)

Intervention Type: OTHER

Other Intervention Names

Dextenza; EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esen Akpek, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Wilmer Eye Institute, Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00246348

Identifier Type: -

Identifier Source: org_study_id