Dry EyePhase 4NCT04498468

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

A Phase 4 study testing Sustained Release Dexamethasone, 0.4 mg and E-Caprolactone-L-Lactide copolymer (PCL) punctal plug in people with Dry Eye, run by Johns Hopkins University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for: Dry Eye
What is being tested?: Sustained Release Dexamethasone, 0.4 mg and E-Caprolactone-L-Lactide copolymer (PCL) punctal plug
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2021to 3 Mar 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

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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:
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):
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.

Who cannot join

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)

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wilmer Eye Institute, Johns Hopkins School of Medicine
Baltimore, Maryland, 21287

Other trials in United States

About this study

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

Read the 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
Being tested: Sustained Release Dexamethasone, 0.4 mg, E-Caprolactone-L-Lactide copolymer (PCL) punctal plug
Keywords: ocular surface disease, dexamethasone, ophthalmic steroids, keratoconjuntivitis sicca, dry eye
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sustained Release Dexamethasone, 0.4 mgDrug
Also called Dextenza
dexamethasone 0.4mg lacrimal insert
E-Caprolactone-L-Lactide copolymer (PCL) punctal plugOther
Also called EXTENDED WEAR SYNTHETIC ABSORBABLE 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)

Study groups in NCT04498468
Study group	Role	What they receive
Treatment Arm	Experimental	Commercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA) Receives: 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) Receives: Other: E-Caprolactone-L-Lactide copolymer (PCL) punctal plug

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 28 Days

Secondary outcomes (2)

Percentage of Subjects Achieving 2 Severity Grade Improvement in Corneal Staining
Corneal staining responder analysis. Responder is defined as two full severity grade improvement in corneal staining. The percentage of subjects achieving two severity grades improvement in corneal staining (responders) in the treated arm versus sham arm will be compared statistically.
Measured: 42 days
Percentage of Subjects Achieving Improvement in Their Most Bothersome Symptom
Symptom responder analysis. Responder is defined as 30% or more improvement in the most bothersome symptom (VAS score is decreased by 30 points or more). The percentage of subjects achieving a 30% improvement in their most bothersome symptom (responders) in the treated arm versus the sham arm will be compared statistically.
Measured: 42 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 20213 Mar 2023

First posted4 Aug 2020
Study start16 Mar 2021
Primary completion3 Mar 2023
Study completion3 Mar 2023

Why it stopped: The study was terminated prematurely due to administrative reasons; loss of several research personnel. Because of strict eligibility criteria, the investigators anticipated delays in completing enrollment and therefore decided to terminate early.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry EyeStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Model description: Prospective, Double Masked, Interventional Study.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04498468
Sponsor's protocol ID: IRB00246348
Status last verified: Mar 2024
First submitted: 28 Jul 2020
Last updated: 15 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Aggregated information only will be shared with sponsor

Publications

Lin MX, Guo L, Saldanha IJ, VanCourt S, Zeng J, Karakus S, Hessen M, Li G, Akpek EK. Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial. Ophthalmology. 2024 Sep;131(9):1033-1044. doi: 10.1016/j.ophtha.2024.03.010. Epub 2024 Mar 15.
PubMed 38492864

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Dexamethasone Ophthalmic Insert (Dextenza®) in the Management of Clinically Significant Dry Eye
ClinicalTrials.gov ID: NCT04498468
Acronym / sponsor ID: IRB00246348
Conditions: Dry Eye
Keywords: ocular surface disease, dexamethasone, ophthalmic steroids, keratoconjuntivitis sicca, dry eye
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated prematurely due to administrative reasons; loss of several research personnel. Because of strict eligibility criteria, the investigators anticipated delays in completing enrollment and therefore decided to terminate early.
Enrolment: 77 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 16 Mar 2021 (actual)
Primary completion: 3 Mar 2023 (actual)
Study completion: 3 Mar 2023 (actual)
First posted: 4 Aug 2020 (actual)
Results: Posted 15 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Prospective, Double Masked, Interventional Study.

Arm	Type	Receives
Treatment Arm	Experimental	Drug: Sustained Release Dexamethasone, 0.4 mgCommercially available Sustained Release Dexamethasone, 0.4 mg intracannalicular insert (DEXTENZA® - Ocular Therapeutix, Bedford, MA)
Control Arm	Sham comparator	Other: E-Caprolactone-L-Lactide copolymer (PCL) punctal plugCommercially available EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL) (Vera90™ - Elkridge, MD)

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sustained Release Dexamethasone, 0.4 mgAlso: Dextenzadexamethasone 0.4mg lacrimal insert	Drug	Treatment Arm
E-Caprolactone-L-Lactide copolymer (PCL) punctal plugAlso: EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUGControl 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)	Other	Control Arm

Primary outcome

Efficacy Endpoint as Assessed by Dry Eye Sign Using Ocular Surface Scale (OSS)
Time frame: 28 days
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.
Patient Reported Symptom
Time frame: 28 Days
(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.

2 secondary outcomes

Percentage of Subjects Achieving 2 Severity Grade Improvement in Corneal Staining
Time frame: 42 days
Percentage of Subjects Achieving Improvement in Their Most Bothersome Symptom
Time frame: 42 days

Results and safety

Results posted to the registry on 15 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	77	74

Primary outcome: Efficacy Endpoint as Assessed by Dry Eye Sign Using Ocular Surface Scale (OSS)

Time frame: 28 days. Mean (Standard Deviation). Unit: score on a scale

Measure	Treatment Arm n = 75	Control Arm n = 75
Day 28 Corneal Staining Mean Staining	2.15 (1.31)	2.70 (1.33)
Day 28 Corneal Staining Mean Staining - Subgroup 18-59	2.14 (1.29)	2.64 (1.55)
Day 28 Corneal Staining Mean Staining - Subgroup 60+	2.13 (0.36)	3.06 (1.12)
Day 28 Corneal Staining Subgroup analysis by Sjögren's status - Yes	2.54 (1.20)	3.23 (1.42)
Day 28 Corneal Staining Subgroup analysis by Sjögren's status - No	1.82 (1.43)	2.59 (1.23)
Day 28 Conjunctival Staining Mean Staining	3.01 (1.89)	3.69 (1.69)
Day 28 Conjunctival Staining Mean Staining - Subgroup 18-59	3.50 (2.35)	2.69 (1.89)
Day 28 Conjunctival Staining Mean Staining - Subgroup 60+	2.69 (1.89)	3.88 (1.41)

Treatment Arm vs Control Arm: Mean Difference (Final Values): -0.55 (95% CI -0.91 to -0.19), p = 0.003, t-test, 2 sided
Treatment Arm vs Control Arm: Mean Difference (Final Values): -0.50 (95% CI -1.28 to 0.28), p = 0.19, t-test, 2 sided
Treatment Arm vs Control Arm: Mean Difference (Final Values): -0.94 (95% CI -1.86 to -0.02), p = 0.047, t-test, 2 sided

Population analysed: Only 75 (150 eyes) patients' data were analyzed as 2 patients were lost to follow-up before 28 days.

Primary outcome: Patient Reported Symptom

Time frame: 28 Days. Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment Arm n = 75	Control Arm n = 75
Day 28 Eye Dryness VAS Mean Score	49.3 (26.4)	54.8 (23.0)
Day 28 Eye Discomfort VAS Mean Score	50.3 (27.7)	50.6 (26.0)
Day 28 Eye Fatigue VAS Mean Score	43.7 (27.5)	45.0 (26.7)

Treatment Arm vs Control Arm: Mean Difference (Final Values): -5.5 (95% CI -11.4 to 0.4), p = 0.069, t-test, 2 sided
Treatment Arm vs Control Arm: Mean Difference (Final Values): -0.3 (95% CI -7.0 to 6.3), p = 0.92, t-test, 2 sided
Treatment Arm vs Control Arm: Mean Difference (Final Values): -1.3 (95% CI -5.8 to 3.1), p = 0.55, t-test, 2 sided

Population analysed: Only 75 (150 eyes) patients' data were analyzed as 2 patients were lost to follow-up before 28 days.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 42 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	1 of 77 (1.3%)	19 of 77 (24.7%)	0 of 77
Control Arm	1 of 77 (1.3%)	10 of 77 (13%)	0 of 77

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38492864Lin MX, Guo L, Saldanha IJ, VanCourt S, Zeng J, Karakus S, Hessen M, Li G, Akpek EK. Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial. Ophthalmology. 2024 Sep;131(9):1033-1044. doi: 10.1016/j.ophtha.2024.03.010. Epub 2024 Mar 15.
Individual participant dataSharing planned: No. Aggregated information only will be shared with sponsor

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Esen Akpek, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Endpoint as Assessed by Dry Eye Sign Using Ocular Surface Scale (OSS) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04498468, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.