Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes

NCT04728646 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2020P003125
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of Dextenza intracanalicular insert in patients with ocular graft-versus-host disease (GVHD).

Conditions

Graft Vs Host Disease

Keywords

graft vs Host disease; GVHD; Dextenza; eye; ocular surface disease

Outcome Measures

Primary Outcomes (3)

• Corneal Fluorescein Staining Score

  Difference in the reduction of corneal fluorescein staining (CFS) compared to the contralateral eye. The cornea is divided into five zones (central, superior, temporal, nasal, and inferior) and for each zone, the severity of corneal fluorescein staining is graded on a scale from 0 to 3. Therefore, the maximum score is 15 for each eye. A higher score correlates to higher severity.

  4 weeks

• Lissamine green staining score

  The difference in the reduction of lissamine green staining compared to the contralateral eye. Six regions are graded for each eye (3 nasal conjunctival regions and 3 temporal conjunctival regions) from 0-3. Thus, a maximum score of 18 is possible for each eye. A higher score correlates to higher severity.

  4 Weeks

• Symptomatic Relief

  The difference in symptomatic relief from baseline to 4 weeks, as compared to the contralateral eye using The Symptom Assessment Questionnaire iN Dry Eye Questionnaire (SANDE). SANDE is a visual analog scale questionnaire that quantifies the severity and frequency of dry eye symptoms. Subjects mark on a 100 mm horizontal linear visual analog scale, with a pen or pencil, their frequency, and severity. By measuring, in mm, where each scale was marked, a score can be obtained, from 0 to 100, where a higher score correlates to more frequent and more severe symptoms.

  4 Weeks

Secondary Outcomes (3)

• The Symptom Assessment Questionnaire iN Dry Eye Questionnaire

  8 Weeks

• Schirmer's Test

  8 Weeks

• Tear Break Up Time

  8 Weeks

Study Arms (2)

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

EXPERIMENTAL

All patients will receive Dextenza insert in one eye and a regular dissolvable intracanalicular plug in the fellow-eye (randomized).

Drug: DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

Dissolvable intracanalicular plug

OTHER

All patients will receive Dextenza insert in one eye and a regular dissolvable intracanalicular plug in the fellow-eye (randomized).

Device: Regular dissolvable intracanalicular plug

Interventions

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use DRUG

Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)

DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

Regular dissolvable intracanalicular plug DEVICE

Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)

Dissolvable intracanalicular plug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients diagnosed as chronic ocular GVHD
• Age \>= 18 years
• Corneal Fluorescein Staining ≥ 4
• Ocular Surface Disease Index ≥22.

You may not qualify if:

• History of immune diseases other than GVHD, herpetic keratitis or ocular malignancy
• Treatment regimen changes with topical cyclosporine, autologous serum, anakinra, or oral tetracycline compounds within 30 days prior to enrollment;
• Treatment regimen changes with systemic immunosuppressants or topical anti-glaucoma medications within 15 days prior to enrollment
• Current use of topical steroids more than twice a day
• Current or history of steroid induced ocular hypertension or glaucoma
• Family history of steroid induced ocular hypertension or glaucoma
• History of any intra-ocular surgery in the past 3 months or contact lens use within 2 weeks prior to enrollment
• History of collagen (prolong) intra-canalicular plug within 6 months
• Inability to cooperate for a comprehensive ocular examination
• History of lid deformity or neuroparalytic lid disease
• Active ocular infection including herpetic disease

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (1)

Mass Eye and Ear

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The randomization results will also be communicated to the treating physician, who will administer the Dextenza and control plug in the respective eyes while keeping the patient blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Epidemiology for Ophthalmology

Model Details: Eyes of enrolled patients will be randomized to treatment arms in a 1:1 ratio (Dextenza insert:control insert). All study participants will receive the Dextenza insert in the lower puncta of one eye (treatment eye) and a standard dissolvable intracanalicular plug in the lower puncta of the fellow eye (control eye).

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 28, 2021
• Study Start: September 1, 2021
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12

Locations

US (1)