Dry Eye SyndromesPhase 4NCT04413253
Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease
A Phase 4 study testing Lifitegrast 5% Ophthalmic Solution and Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution in people with Dry Eye Syndromes, run by Eye Surgeons of Indiana at 1 site in United States.
Trial summary
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Lifitegrast 5% Ophthalmic Solution and Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 11 Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, 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:
- 18 years of age or older
- Signs and symptoms of DED
- Consent to treat with topical immunomodulator
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Who cannot join
- A patient who meets any of the following criteria will be excluded from the study:
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Altered nasolacrimal flow of either acquired, induced, or congenital origin
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- Hypersensitivity to dexamethasone
- Patients who have been on topical immunomodulating agents in the previous 3 months to their baseline visit
- Patient being treated with either topical, oral, or intravenous immunosuppressive agents, immunomodulating agents, or steroid (including NSAIDS)
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Surgeons of Indiana
Indianapolis, Indiana, 46040
About this study
Official title: Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.
Read the detailed description
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.
- Conditions
- Dry Eye Syndromes
- Being tested
- Lifitegrast 5% Ophthalmic Solution, Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution
- 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.
Lifitegrast 5% Ophthalmic SolutionDrug
Also called Xiidra
To reduce signs and symptoms of dry eye disease
Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic SolutionDrug
Also called Dextenza, Xiidra
To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.
| Study group | Role | What they receive |
|---|---|---|
| Xiidra Only Group | Active comparator | Patients with dry eye disease Xiidra only Receives: Drug: Lifitegrast 5% Ophthalmic Solution |
| Xiidra + Dextenza Group | Experimental | Patients with dry eye disease Xiidra + Dextenza Receives: Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Ocular Surface Staining
As measured by sodium fluorescein and lissamine green
Measured: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Patient Preference for Therapy
As measured by COMTOL Survey
Measured: Assessed at Week 12 Visit
Secondary outcomes (7)
Mean Change in MMP-9
As measure by InflammaDry
Measured: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in Conjunctival Injection
As measured on a scale of 0-4 and graded by the physician
Measured: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Change From Baseline in Meibomian Gland Scores (Expressibility and Quality)
As measured on a grading scale 1 to 4 and graded by the physician
Measured: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in Tear Break-up Time (TBUT)
As measured by TBUT testing
Measured: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in Tear Osmolarity
As measured by Tear Lab
Measured: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in DEQ-5
As measured by the DEQ-5 Questionnaire
Measured: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in Best-corrected Visual Acuity (BCVA)
As measure by ETDRS
Measured: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Aug 2020
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Why it stopped: Unable to recruit
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.
- Other trials for Dry Eye SyndromesStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Surgeons of Indiana
- Sponsor type
- Research network
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor
- Investigators
- Damon Dierker, OD, FAAO, Principal investigator, Eye Surgeons of Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413253
- Sponsor's protocol ID
- The DAMON Study
- Status last verified
- Oct 2026
- First submitted
- 28 May 2020
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracanalicular Dexamethasone Used in Conjunction With Xiidra (Lifitegrast Ophthalmic Solution) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Xiidra Alone
- ClinicalTrials.gov ID
- NCT04413253
- Acronym / sponsor ID
- The DAMON Study
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Eye Surgeons of IndianaResearch network
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in patients with dry eye who are beginning treatment with Xiidra (lifitegrast ophthalmic solution) to reduce the signs and symptoms of dry eye disease.
Detailed description
This prospective study will use a fellow-eye design for 20 participants, 40 eyes. All eyes will receive bilateral Xiidra. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day Xiidra is prescribed (study eye), while the other eye will be assigned to receive sham punctum dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 20 eyes receiving DEXTENZA® insertion. The control group will consist of 20 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xiidra Only Group | Active comparator | Drug: Lifitegrast 5% Ophthalmic SolutionPatients with dry eye disease Xiidra only |
| Xiidra + Dextenza Group | Experimental | Drug: Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic SolutionPatients with dry eye disease Xiidra + Dextenza |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- A patient's study eye must meet the following criteria to be eligible for inclusion in the study:
- 18 years of age or older
- Signs and symptoms of DED
- Consent to treat with topical immunomodulator
- Willing and able to comply with clinic visits and study related procedures
Key exclusion criteria (10 listed)
- Patients under the age of 18.
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Altered nasolacrimal flow of either acquired, induced, or congenital origin
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 |
|---|---|---|
| Lifitegrast 5% Ophthalmic SolutionAlso: XiidraTo reduce signs and symptoms of dry eye disease | Drug | Xiidra Only Group |
| Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic SolutionAlso: Dextenza, XiidraTo determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy. | Drug | Xiidra + Dextenza Group |
Primary outcome
Mean Change in Ocular Surface Staining
Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
As measured by sodium fluorescein and lissamine green
Patient Preference for Therapy
Time frame: Assessed at Week 12 Visit
As measured by COMTOL Survey
7 secondary outcomes
Mean Change in MMP-9
Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in Conjunctival Injection
Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Change From Baseline in Meibomian Gland Scores (Expressibility and Quality)
Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in Tear Break-up Time (TBUT)
Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in Tear Osmolarity
Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in DEQ-5
Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Mean Change in Best-corrected Visual Acuity (BCVA)
Time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Damon Dierker, OD, FAAO principal investigator
Eye Surgeons of Indiana
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 Lifitegrast 5% Ophthalmic Solution and Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution in people with Dry Eye Syndromes, run by Eye Surgeons of Indiana 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 6 inclusion and 10 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 27 Oct 2026. 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. 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 27 Oct 2026). 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?
Mean Change in Ocular Surface Staining (time frame: Assessed at Baseline, Week 1, Week 2, Week 4 and Week 12 Visit). 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?
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 27 Oct 2026.