Dry EyePhase 4DEcIDEDNCT04527887
Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease (DEcIDED)
A Phase 4 study testing Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) and ProLong™ collagen plugs in people with Dry Eye, run by Tufts Medical Center at 1 site in United States.
Trial summary
This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) and ProLong™ collagen plugs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2020to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Dry Eye Disease
- Objective Signs (Schirmer's II test <10 mm at 5 min; Tear Break-Up time (TBUT) of <10 seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival lissamine green staining of the nasal and temporal conjunctive >=4 in at least 1 eye)
- Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy
Who cannot join
- History of Diabetes
- History of ocular surgery, corneal infection, or corneal injury within the last 3 months
- Active ocular allergies
- Active ocular infection
- Allergic to benzalkonium chloride
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease
This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.
- Conditions
- Dry Eye
- Being tested
- Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg), ProLong™ collagen plugs
- 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.
Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)Drug
Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of postsurgical inflammation and pain associated with ocular surgery.
ProLong™ collagen plugsOther
The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length.
| Study group | Role | What they receive |
|---|---|---|
| Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg) | Active comparator | intracanalicular dexamethasone insert Receives: Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) |
| ProLong™ collagen plugs | Placebo comparator | collagen plug Receives: Other: ProLong™ collagen plugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocular inflammation
As measured by change to dendritic cell density and ocular redness
Measured: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Secondary outcomes (7)
Clinical Parameter: Ocular Surface Disease Index (OSDI)
12-item scale; score ranges from 0 to 100 and is calculated by the sum of the scores for all 12 questions answered multiplied by 100, which is divided by the total number of questions answered times four
Measured: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Ocular Pain Assessment Survey (OPAS)
32-questions, 8-domain questionnaire using numerical rating scales to assess eye pain intensity (worse eye) in the past 24 hours and 2 weeks (worst, least and average pain intensity), frequency of eye and non-eye pain (past 24 hours and 2 weeks), non-eye pain intensity (past 24 hours and 2 weeks), impact on QoL, pre-occupation with eye and non-eye pain, aggravating factors and associated factors.)
Measured: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)
Score is calculated by multiplying the frequency of symptoms score with the severity of symptoms score and obtaining the square root.
Measured: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Tear Break Up Time (TBUT)
The standard TBUT measurement will be performed by dropping a fluorescein drop to the inferior tarsal conjunctiva and waiting 30 seconds. After several blinks, the tear film will be examined. The time lapse between the last blink and the appearance of the first randomly distributed dark discontinuity in the fluorescein stained tear film will be measured three times and the mean value of the measurements will be calculated.
Measured: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Conjunctival staining
Grading of conjunctival lissamine green staining will be performed after 1 minutes of application of a lissamine green drop. Staining will be graded using the National Eye Institute (NEI) grading scheme, with a total range of 0-18.
Measured: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Corneal staining with fluorescein
Corneal fluorescein staining will be performed after 2 minutes of application of a fluorescein drop. Staining will be graded using the National Eye Institute (NEI) grading scheme, with a total range of 0-15.
Measured: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Schirmer II test
Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes.
Measured: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start4 Sep 2020
- Primary completion17 Nov 2023
- Study completion31 Dec 2024
Why it stopped: Per sponsor decision due to lengthy enrollment period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527887
- Sponsor's protocol ID
- STUDY00000084
- Acronym
- DEcIDED
- Status last verified
- Jan 2025
- First submitted
- 19 Feb 2020
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracanalicular Dexamethasone Insert for the Treatment of Inflammation and Discomfort in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04527887
- Acronym / sponsor ID
- DEcIDED / STUDY00000084
- Conditions
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per sponsor decision due to lengthy enrollment period
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-center, randomized, double-masked, parallel comparison, sponsored study seeks to investigate the efficacy of Intracanalicular dexamethasone Insert (IDI) on ameliorating the signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg) | Active comparator | Drug: Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)intracanalicular dexamethasone insert |
| ProLong™ collagen plugs | Placebo comparator | Other: ProLong™ collagen plugscollagen plug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Dry Eye Disease
- Objective Signs (Schirmer's II test <10 mm at 5 min; Tear Break-Up time (TBUT) of <10 seconds in 1 eye; corneal fluorescein staining of .=4 in at least 1 eye; conjunctival lissamine green staining of the nasal and temporal conjunctive >=4 in at least 1 eye)
- Ocular inflammation presence confirmed by In-Vivo Confocal Microscopy
Key exclusion criteria (5 listed)
- History of Diabetes
- History of ocular surgery, corneal infection, or corneal injury within the last 3 months
- Active ocular allergies
- Active ocular infection
- Allergic to benzalkonium chloride
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 |
|---|---|---|
| Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of postsurgical inflammation and pain associated with ocular surgery. | Drug | Dextenza (IDI) (Sustained Release Dexamethasone, (0.4 mg) |
| ProLong™ collagen plugsThe long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length. | Other | ProLong™ collagen plugs |
Primary outcome
Change in ocular inflammation
Time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
As measured by change to dendritic cell density and ocular redness
7 secondary outcomes
Clinical Parameter: Ocular Surface Disease Index (OSDI)
Time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Ocular Pain Assessment Survey (OPAS)
Time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Symptom Assessment in Dry Eye scores (SANDE)
Time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Tear Break Up Time (TBUT)
Time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Conjunctival staining
Time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Corneal staining with fluorescein
Time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Clinical Parameter: Schirmer II test
Time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug
Results and safety
The study was stopped early (reason given: Per sponsor decision due to lengthy enrollment period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Pedram Hamrah, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg) and ProLong™ collagen plugs in people with Dry Eye, run by Tufts Medical Center at 1 site in United States.
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 3 inclusion and 5 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 Jan 2025. 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?
The study was stopped early (reason given: Per sponsor decision due to lengthy enrollment period). Results are not available in the source record.
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?
Change in ocular inflammation (time frame: Change from Baseline one month after intracanalicular insert implantation or punctal plug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2025.