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

NCT04498468 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00246348
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye

Keywords

ocular surface disease; dexamethasone; ophthalmic steroids; keratoconjuntivitis sicca; dry eye

Outcome Measures

Primary Outcomes (2)

• Efficacy Endpoint as Assessed by Dry Eye Sign Using Ocular Surface Scale (OSS)

  OSS will be graded according to the Sjögren's International Collaborative Clinical Alliance (SICCA) grading system. Maximum possible fluorescein score (the punctate epithelial erosions grade + any extra points for modifiers \[central staining, confluent staining, and filaments\]) will be 6 and minimum of 0. Maximum possible conjunctival staining score (the punctate epithelial erosions grade on the temporal and nasal sides) will be 6 and minimum of 0. The total possible maximum OSS, derived by summing the corneal and conjunctival scores, will be 12 for each eye, and minimum OSS will be 0. Higher corneal, conjunctival, and staining scores represent worse outcomes. The difference between the average corneal staining in the treated arm versus the average corneal staining in the sham arm will be compared statistically.

  28 days

• Patient Reported Symptom

  (1)eye dryness, (2)eye discomfort, or (3)eye fatigue will be measured using visual analogue scale (0 to 100). The difference between the average bothersome symptom in the treated arm versus the average most bothersome symptom in the sham arm will be compared statistically. Higher VAS scores indicate worse eye dryness, discomfort, or fatigue.

  28 Days

Secondary Outcomes (2)

• Percentage of Subjects Achieving 2 Severity Grade Improvement in Corneal Staining

  42 days

• Percentage of Subjects Achieving Improvement in Their Most Bothersome Symptom

  42 days

Other Outcomes (1)

• Percentage of Participants With Intraocular Pressure Increase

  At day 30 and day 42

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Drug: Sustained Release Dexamethasone, 0.4 mg

Control Arm

SHAM COMPARATOR

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

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

Interventions

Sustained Release Dexamethasone, 0.4 mg DRUG

dexamethasone 0.4mg lacrimal insert

Also known as: Dextenza

Treatment Arm

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

Also known as: EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG

Control Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute, Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Calcium Dobesilate; Punctal Plugs

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Prostheses and Implants; Equipment and Supplies

Limitations and Caveats

The study was not able to enroll its planned sample size. VAS, while consistently used in measuring clinical symptoms of illnesses, is limited in that patients may encounter difficulties in rating their symptomology, especially if the participants feel ambivalent towards the VAS prompts.

Results Point of Contact

• Title: Michael Lin, BA, Research coordinator
• Organization: Johns Hopkins Wilmer Eye Institute

mlin60@jhu.edu

8653851192

Study Officials

• Esen Akpek, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the examining physician/outcomes accessor will be masked. The treating physician cannot be masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, Double Masked, Interventional Study.

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 4, 2020
• Study Start: March 16, 2021
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)